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U.S. Department of Health and Human Services

Enforcement Report - Week of July 15, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Foil bags containing 2.2 lbs. each of almond flavored powder and sold under the Boba Direct, Inc. brand. Product code: AlmndPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of avocado flavored powder and sold under the Boba Direct, Inc. brand. Product code: AvoPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of banana flavored powder and sold under the Boba Direct, Inc. brand. Product code: BanaPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of blueberry flavored powder and sold under the Boba Direct, Inc. brand. Product code: BlueberryPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of cafe latte flavored powder and sold under the Boba Direct, Inc. brand. Product code: CafelattePwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of cherry flavored powder and sold under the Boba Direct, Inc. brand. Product code: CherryPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of chocolate flavored powder and sold under the Boba Direct, Inc. brand. Product code: ChocPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of coconut flavored powder and sold under the Boba Direct, Inc. brand. Product code: CoconutPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of honeydew flavored powder and sold under the Boba Direct, Inc. brand. Product code: HnydewPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of lavender flavored powder and sold under the Boba Direct, Inc. brand. Product code: LavPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of lychee flavored powder and sold under the Boba Direct, Inc. brand. Product code: LycheePwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of mango flavored powder and sold under the Boba Direct, Inc. brand. Product code: MangoPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of matcha green tea flavored powder and sold under the Boba Direct, Inc. brand. Product code: MachaGrnTea-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of milk tea flavored powder and sold under the Boba Direct, Inc. brand. Product code: MlkTeaPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of passion fruit flavored powder and sold under the Boba Direct, Inc. brand. Product code: PassionPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of peppermint flavored powder and sold under the Boba Direct, Inc. brand. Product code: PepperPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of pineapple flavored powder and sold under the Boba Direct, Inc. brand. Product code: PinePwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of red bean flavored powder and sold under the Boba Direct, Inc. brand. Product code: RedBeanPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of strawberry flavored powder and sold under the Boba Direct, Inc. brand. Product code: StrawPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of taro flavored powder and sold under the Boba Direct, Inc. brand. Product code: TaroPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of vanilla flavored powder and sold under the Boba Direct, Inc. brand. Product code: VanillaPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of watermelon flavored powder and sold under the Boba Direct, Inc. brand. Product code: WtrmlnPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of spiced chai flavored powder and sold under the Boba Direct, Inc. brand. Product code: SpChaiPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Food Foil bags containing 2.2 lbs. each of green tea flavored powder and sold under the Boba Direct, Inc. brand. Product code: GrTeaPwdr-BD; All lots Class II Bubble tea powders contain undeclared allergens. Boba Direct, Inc.
Drugs SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. Lot # 140430; Exp.12/17 Class I Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis. Bethel Nutritional Consulting, Inc
Food Spicy Black Bean Burger powder mix, packaged in 30 LB poly-lined Kraft bags. The following lots are affected by this recall: C17SEP2014B95, C18SEP2014B102, C23SEP2014B123, C10OCT2014B195, C13OCT2014B203, C14OCT2014B207, C18OCT2014B223, C20OCT2014B229, C24OCT2014B250, C28OCT2014B265, C01NOV2014B287, C04NOV2014B296, C05NOV2014B299, C03DEC2014B401, C03DEC2014B402, C05DEC2014B414, C09DEC2014B432, C11DEC2014B440, C12DEC2014B450, C19DEC2014B473, C20DEC2014B481, and C23DEC2014B481. Class II Undeclared peanuts in spicy black bean burger powder mix. Coalescence LLC
Food Cumin, Ground NET WT. 50 LBS. DISTRIBUTED BY: SOUTHERN STYLE SPICES PO BOX 20 MANOR, TX 78653 PHONE: (512)272-5621 Lot: CUGR-14199 and CUGR-14238 Class II The ground cumin may contain peanut protein. Southern Style Spices
Food Ancho & Molasses Barbecue Sauce, Rub with Love brand, Net wt. 16 oz., UPC 6-72361-00044-1 Best by date: 12/1/2015. Lot codes: 33714-6; 33714-7; 33714-8; 33714-9; 33714-10. Class II Ancho & Molasses Barbecue Sauce, Rub with Love brand, containing ground cumin, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Chili Barbecue Sauce, Traeger brand, Net Wt. 12.9 oz. UPC 6-34868-91093-7 Best by date: none Lot code: 27614-15 Class II Chili Barbecue Sauce, Traeger brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Cilantro Salsa, All Natural Medium, Hazelwood's brand, Net Wt. 16 oz. (454 g), UPC 8-52707-00206-7 Best by date: 7/2/2016. Lot code: 00215-4 Class II Cilantro Salsa, All Natural Medium, Hazelwood's brand, containing ground cumin ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Extra Spicy Stir Fry Marinade BBQ Sauce, the Hungry Dragon brand, Net Wt. 22 oz (623 g), UPC 7-01505-61996-5. The label has the advisory statement: Produced in a facility that handles peanut, tree nuts, eggs, milk, wheat, and soy. Best By date: 12/4/2015 Lot code: 33814-7 Class II Extra Spicy Stir Fry Marinade BBQ Sauce, the Hungry Dragon brand, containing mild chili powder, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Hot Pineapple Smash Salsa, Soog Head brand, Net Wt. 16 oz. (453 g), UPC 6-26570-62022-8 Best by Date: 4/8/2016 Lot code: 28114-8 Class II Hot Pineapple Smash Salsa, Soog Head brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Habanero Salsa, All Natural Hot, Hazelwood's brand, Net wt. 16 oz. (454 g), UPC 8-52707-00204-3 Best by Date: 7/2/2016 Lot code: 00215-6 Class II Habanero Salsa, All Natural Hot, Hazelwood's brand, containing ground cumin and mild chili powder ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Hot Salsa, D.A.M. brand, Net Wt. 16 oz (454 g), UPC 1-87283-00000-9 Best by Date: 5/14/16 and 6/12/2016 Lot codes: 31814-3; 34614-7; 34614-8; 34614-9; Class II Hot Salsa, D.A.M. brand, containing ground cumin, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Korma Simmer Sauce, Masala Maza brand, Net Wt. 12 oz. (340 g), UPC 6-48253-10101-5. The label has the advisory statement: Made in a facility that uses peanut, tree nut, egg, milk, wheat, and soybeans. Best By Dates: 10/13/16; 12/30/16. Lot codes: 28614-8; 36414-7. Class II Korma Simmer Sauce, Masala Maza brand, containing ground cumin, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Medium Pineapple Smash Salsa, Soog Head brand, Net Wt. 16 oz (453 g), UPC 6-26570-62023-5 Best By Date: 4/8/2016 Lot code: 28114-7 Class II Medium Pineapple Smash Salsa, Soog Head brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Mild Pineapple Smash Salsa, Soog Head brand, Net Wt. 16 oz (453 g), UPC 6-26570-62024-2 Best By Date: 4/8/2016; Lot Codes: 28114-4; 28114-5; 28114-6; Class II Mild Pineapple Smash Salsa, Soog Head brand, containing mild chili powder ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Medium Salsa, D.A.M brand, Net Wt. 16 oz (453 g), UPC 1-87283-00002-3 Best by date: 6/12/2016 Lot codes: 34614-4; 34614-5; 34614-6; Class II Medium Salsa, D.A.M brand, containing ground cumin ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Mild Salsa, D.A.M brand, Net Wt. 16 oz (453 g), UPC 1-87283-00001-6 Best by date: 6/12/2016 Lot Codes: 34614-1; 34614-2; 34614-3; Class II Mild Salsa, D.A.M brand, containing ground cumin, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Spicy Maria Salsa, D.A.M. brand, Net Wt. 16 oz (453 g), UPC 1-87283-00003-0 Best by date: 5/14/2016 Lot code: 31814-4 Class II Spicy Maria Salsa, D.A.M. brand, containing ground cumin ingredient, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Salsa, All Natural Mild, Hazelwood's brand, Net Wt. 16 oz (453 g), UPC 8-52707-00202-9 Best by date: 7/2/2016 Lot codes: 00215-1; 00215-2; 00215-3; Class II Salsa, All Natural Mild, Hazelwood's brand, containing ground cumin and mild chili powder ingredients, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Smoky Sweet Salsa, All Natural Medium, Hazelwood's brand, Net Wt. 16 oz (453 g), UPC 8-52707-00200-5 Best By Date: 7/2/2016; Lot code:00215-5; Class II Smoky Sweet Salsa, All Natural Medium, Hazelwood's brand, containing ground cumin, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Original Flavor Stir Fry Marinade BBQ Sauce, The Hungry Dragon brand, Net Wt. 22 oz (623 g), UPC 7-05105-61946-0 The label has the advisory statement: Produced in a facility that handles peanut, tree nuts, eggs, milk, wheat, and soy. Best By Date: 12/4/2015 Lot code: 33814-6 Class II Original Flavor Stir Fry Marinade BBQ Sauce, The Hungry Dragon, containing mild chili powder, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Mild BBQ Sauce, Ooga Booga brand, Net wt. 17. 6 oz (498 g), UPC 8-13012-00435-1 Lot Codes: 28614-6 and 34514-5 Best by dates: NONE Class II Mild BBQ Sauce, Ooga Booga brand, containing ground cumin and mild chili powder, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food N'Between BBQ Sauce, Ooga Booga brand, Net wt. 17. 2 oz (498 g), UPC 8-13012-00437-5 Lot Codes: 28614-7; 34514-4; and 00715-8 Best by Dates: NONE Class II N'Between BBQ Sauce, Ooga Booga brand, containing ground cumin and mild chili powder, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Wild BBQ Sauce, Ooga Booga brand, Net wt. 17. 6 oz (498 g), UPC 8-13012-00436-8 Lot code: 00715-9 Best by Dates: NONE Class II Wild BBQ Sauce, Ooga Booga brand, containing ground cumin and mild chili powder, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Food Oregon Microbrew BBQ Sauce, Paradigm and Fess Parker brand, net wt. 12 fl. oz. (343 mL). The Paradigm has the UPC 0-37644-30520-8. The Fess Parker brand does not have UPC. The advisory statement on label is read "Made in a facility that handles peanuts, tree nuts, eggs, milk, wheat, soybeans, and fish". Best By Date: 12/4/2016 Lot code: 33814-10 Class II Microbrew BBQ Sauce containing mild chili powder, is recalled due to potential for contamination with peanut protein. Paradigm Foodworks, Inc
Drugs 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02 Lot #: C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016 Class I Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp.
Drugs 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02 Lot #: C963413 and C963413A, Exp 7/31/2016 Class I Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp.
Drugs 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02 Lot #: C965558 and C963520, Exp 7/31/2016 Class I Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp.
Drugs Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02 Lot #: C964619, C964056 and C964163, Exp 7/31/2016 Class I Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Baxter Healthcare Corp.
Devices Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp. Model: L90C, Lot: BE03356, Class III Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error. Volk Optical Inc
Food New Punjab Burfi is an Indian snack cut into 1lb or 0.5 lb. squares. Product is packaged in clear plastic container with a clear plastic lid. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack may contain undeclared nuts (undeclared almonds, pistachios, and cashews): New Punjab Burfi New Punjab Sweets Inc.
Food New Punjab Kaju Katri is an Indian snack cut into squares. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack may contain undeclared cashews and colors (Yellow 5 & 6): Kaju Katri New Punjab Sweets Inc.
Food New Punjab Kaju Roll is an Indian snack cut into squares. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack may contain undeclared cashews and colors (Yellow 5 & 6): Kaju Roll New Punjab Sweets Inc.
Food New Punjab Kaju (Kajoo) Fry is the Indian translation for Toasted Fried Cashews. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack may contain undeclared cashew nuts: Kaju Fry New Punjab Sweets Inc.
Food New Punjab Ladoo is a ball-shaped Indian snack coated with almonds and/or pistachios. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack lacks an ingredient label. Product may contain undeclared nuts (almonds, pistachios), undeclared colors (Yellow 5&6, Blue 1), and wheat-uses the term farina: Ladoo New Punjab Sweets Inc.
Food New Punjab Chum Chum is a oval-shaped Indian snack coated with almonds and/or coconuts. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack may contain undeclared almonds, undeclared coconut, undeclared colors (Yellow 5&6, Blue 1), and wheat-uses the term farina: Chum Chum New Punjab Sweets Inc.
Food New Punjab Rosgula is a ball-shaped Indian snack. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs. Company does not use a coding system to trace finished products. Class II This voluntary recall is being initiated because the following Indian snack may contain undeclared almonds, undeclared colors (Yellow 5&6, Blue1), and wheat-uses the term farina: Rosgula New Punjab Sweets Inc.
Drugs Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11 Lot #s: 31317858B, Exp 11/2015; 31317899B, 31317906B, 31317958B, 31317959B, 31318103B, 31318137B, Exp 12/2015; 31318533B, Exp 07/2016 Class I Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Teva Pharmaceuticals USA
Devices Breast Pack - contains Devon Light Glove Used during surgery Pack 693-196, 693-188, 693-166, 693-112, 888-2583 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Basic Pack - contains Devon Light Glove Used during surgery Pack 693-203, 888-2375, 888-2396, 888-2430, 888-2495, 888-2594 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Advanced Vein Care - contains Devon Light Glove Used during surgery Pack 682-956 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during surgery Pack 682-949, 682-937, 682-900, 682-370, 682-218, 682-1264, 682-1529, 682-076, 682-192, 682-962, 682-968, 682-177, 682-394, 682-988, 682-156, 682-063, 682-151, 682-917, 682-250, 682-409, 682-960, 682-945, 682-218, 682-1264, 682-1412, 682-1422 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery Pack 682-156, 682-1548, 682-931, 682-493, 682-263, 682-931, 682-1419, 682-493, 682-044 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery Pack 682-1284, 682-299, 682-410, 682-353, 682-377, 682-548 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Standard Pack - contains Devon Light Glove Used during surgery Pack 681-022A Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery Pack 681-025, 681-268, 681-254, 681-013, 681-506, 888-2587 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery Pack 681-256 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery Pack 693-222 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices General Pack - contains Devon Light Glove Used during surgery Pack 670-115 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Vein & Vascular Pack - contains Devon Light Glove Used during surgery Pack 682-670 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery Pack 682-670, 682-501, 682-547 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery Pack 681-502, 693-177, 681-243, 681-502, 681-502, 693-158, 682-502, 681-503 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Tummy Tuck Pack - contains Devon Light Glove Used during surgery Pack 693-223 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery Pack 40604EBS, 693-152, 40759MMS, 888-2371 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Mississippi Pack - contains Devon Light Glove Used during surgery Pack 682-1302 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Face Lift Pack - contains Devon Light Glove Used during surgery Pack 693-102 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery Pack 693-210, 693-054, 693-219, 888-2479, 888-2499 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Suction Pack - contains Devon Light Glove Used during surgery Pack 670-057 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices ACL Pack - contains Devon Light Glove Used during surgery Pack 693-055 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Hand Pack - contains Devon Light Glove Used during surgery Pack 693-057, 888-2345, 888-2596 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Lima Pack - contains Devon Light Glove Used during surgery Pack 682-927 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Skin and Vein Pack - contains Devon Light Glove Used during surgery Pack 682-1218 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Vasc Custom Kit - contains Devon Light Glove Used during surgery Pack 682-126 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Bariatric Pack - contains Devon Light Glove Used during surgery Pack 682-678 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Face Neck Pack - contains Devon Light Glove Used during surgery Pack 693-167 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery Pack 670-056, 681-014 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Stradi 4500 - contains Devon Light Glove Used during surgery Pack 682-1102 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Gyn Pack - contains Devon Light Glove Used during surgery Pack 693-111 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Head & Neck Pack - contains Devon Light Glove Used during surgery Pack 681-012, 888-2385 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Eye Pack - contains Devon Light Glove Used during surgery Pack 687-191 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Glaucoma Pack - contains Devon Light Glove Used during surgery Pack 687-395 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Shoulder Pack - contains Devon Light Glove Used during surgery Pack 888-2349 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery Pack 888-2359, 888-2531, 888-2351 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices ENT Pack - contains Devon Light Glove Used during surgery Pack 888-2352, 888-2434 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Hand Pack - contains Devon Light Glove Used during surgery Pack 888-2376, 888-2397, 888-2414, 888-2471 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Podiatry Pack - contains Devon Light Glove Used during surgery Pack 888-2378, 888-2411, 888-2429, 888-2553 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery Pack 888-2381, 888-2541 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Neurosurgery Pack - contains Devon Light Glove Used during surgery Pack 888-2489 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Cysto Pack - contains Devon Light Glove Used during surgery Pack 888-2492 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Open Pack - contains Devon Light Glove Used during surgery Pack 888-2493 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Pediatric Pack - contains Devon Light Glove Used during surgery Pack 888-2494 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Face Lift Pack - contains Devon Light Glove Used during surgery Pack 888-2532 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Set Up Pack - contains Devon Light Glove Used during surgery Pack 888-2546 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Blepharoplasty Pack - contains Devon Light Glove Used during surgery Pack 888-2533 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Custom Pack - contains Devon Light Glove Used during surgery Pack 888-2552 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices DND Pack - contains Devon Light Glove Used during surgery Pack 888-2595 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery Pack 888-2604 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Arthroscopy Pack - contains Devon Light Glove Used during surgery Pack 888-2605 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Upper Extremity Pack - contains Devon Light Glove Used during surgery Pack 888-2606 Class II Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Stradis Healthcare, LLC.
Devices Integra® Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra® Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra® Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question. W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181 Class II Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch). Integra LifeSciences Corp. d.b.a. Integra Pain Management
Devices Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P, All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14. Class I Medtronic is voluntarily recalling its Covidien Shiley" Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless and Shiley" Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard" Cuff due to reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels. Medtronic Navigation, Inc.
Devices Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements. All products manufactured since 2/2012. Class I Medtronic is voluntarily recalling its Covidien Shiley" Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless and Shiley" Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard" Cuff due to reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels. Medtronic Navigation, Inc.
Devices Philips GoSafe Communicator 7000L Personal emergency response system. Serial Numbers: 9030003931 9030001761 9030002025 9030002242 9030001588 9030000853 9030001696 9030003178 9030003086 9030000589 9030001526 9030003837 9030000681 9030003507 9030000600 9030001060 9030001517 9030004154 9030002875 Class II Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions. Lifeline Systems, Incorporated
Food DASANI Purified Water, 24/20 fl. oz. (1.25 pt) 591 mL, pack, Desani, The Coca Cola Company, Atlanta, GA 30313. UPC Code: 0 499770 4, Date Codes: MAR 2116 KMA, MAR 2116 KM  ...
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Class II There is the potential that some of the bottles may contain linear pieces of plastic from the bottle production. World of Coca-Cola
Devices Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802 Class II there is the potential for two software issues to occur in Vista software versions 3.6.1 Issue #1 :Samples stop processing without notification for Dimension Vista instruments running software version 3.6.1. Issue#2:The Dimension Vista 1500 causing a series of unflagged, unexpected low results and complaints of results flagged with assay errors. Siemens Healthcare Diagnostics, Inc.
Food Bedessee Brown Betty BRAND COCONUT MILK Powder Mix, NET WT: 1) 1.76 OZ (50 g) and 2) 10.6 OZ. IMPORTED BY BEDESSEE IMPORTS LTD. Brooklyn, NY USA 11208. PRODUCT OF VIETNAM. none Class I Canadian Food Inspection Agency processed a recall involving Brown Betty brand Coconut Milk Powder Mix which contains sodium caseinate but lacks "milk" declaration. Bedessee Imports, Inc
Devices The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis. Dual Arm: Part #569710902 - Serial Numbers: 15664, 15672  ...
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Class II Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table. Maquet Cardiovascular Us Sales, Llc
Food Dill Pickle Lite Works Popcorn , lot number 15111, packaged in a 4 oz foil white bag with black and green lettering. Lot code 15111, Best by date SEP 17, 2015 Class I The product contains an allergen that is not declared on the label (Milk) Popcorn Factory, The
Drugs Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02. Lot #: 38-515-DK, Expiry: 1 FEB 2016. Class I Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. Hospira Inc.
Drugs Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02 Lot #: 39-569-DK, Exp 3/1/2016 Class III Failed pH Specifications:12 month stability testing Hospira Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W20491509045000; W20491509256500; Class II Blood products, collected in a manner that lacked assurance of sterility, were distributed. American National Red Cross SW Region
Biologics Red Blood Cells Leukocytes Reduced W20491509775100; W20491509775700; W20491509720400; W20491509721200; W20491509722500; W20491509722900; W20491509723800; W20491509724400; W20491509665100; W20491509663500; W20491509663900; W20491509664600; W20491509045700; W20491509046100; W20491509255300; W20491509255500; W20491509255800; W20491509256100; W20491509257100; W20491509257600; W20491509258000; W20491509912200; W20491509913200; W20491509916200; W20491509918000; W20491509111100; W20491509111900; W20491509112900; W20491509113200; W20491509113300; W20491509310900; W20491509981000; W20491509981600; W20491509982400; W20491509766000; W20491509766500; W20491509767200; W20491509767900; W20491509163600; W20491509164600; W20491509165700; W20491510067800; W20491510068100; W20491510068800; W20491510069100; W20491510069400; W20491509568200; W20491509568700; W20491509569200; W20491509517900;  ...
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Class II Blood products, collected in a manner that lacked assurance of sterility, were distributed. American National Red Cross SW Region
Biologics Plasma Frozen within 24 hours (FP24) W20491509775700; W20491509071700; W20491509073200; W20491407424800; W20491407425500; W20491405439900; W20491405444700; W20491406722500; W20491406723300; W20491406640400; W20491406642900; W20491406643600; W20491406426500; W20491509405800; W20491509967400; W20491509759200; W20491509665100; W20491509982400; W20491509765800; W20491510068100; W20491509521100; W20491510078600; W20491509774400; W20491509774700; Class II Blood products, collected in a manner that lacked assurance of sterility, were distributed. American National Red Cross SW Region
Devices Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions Class II Volcano Corporation and Philips Healthcare became aware of a limitation in interoperability between the Philips brand Xper Flex Cardia Physio monitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. Volcano Corp
Devices Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. All software versions Class II Volcano Corporation and Philips Healthcare became aware of a limitation in interoperability between the Philips brand Xper Flex Cardia Physio monitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. Volcano Corp
Devices ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Product Usage: The Volcano s5/s5i Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations. The ComboMap is intended to be used in peripheral and coronary arteries to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures. Product/Part numbers: Combo Map - 802745-001. All software versions Class II Volcano Corporation and Philips Healthcare became aware of a limitation in interoperability between the Philips brand Xper Flex Cardia Physio monitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output. Volcano Corp
Drugs Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9 Lot #: KP4726, Exp date 9/2015 Class II Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc.
Drugs Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9 Lot #: KT3819, Exp 11/2015; Lot #: KT3821, Exp 11/2015 Class II Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc.
Drugs Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9 Lot #: KN1449, Exp 06/2015 Class II Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc.
Drugs Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1 Lot #: KP4529, Exp 10/2015 Class II Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Apotex Inc.
Devices PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo" catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. Lot No: REYK1763, Item No. 1194108D Class III Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Bard Access Systems
Devices PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo" catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. Lot No: REYK1762, Item No. 1295108D Class III Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Bard Access Systems
Devices PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo" catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. Lot No: REYK1764, Item No. 9194108 Class III Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Bard Access Systems
Devices PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo" catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. Lot No: REYK1761, Item No. 9194108D Class III Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Bard Access Systems
Devices Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton. Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410. Class II Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. Allergan Inc
Food Kraft Non-Dairy Creamer, Net WT/Contenido Neto 16 oz (454 g) SKU 2100042503. Kraft Non-Dairy Creamer, Net WT/Contenido Neto 6 oz (170g) SKU 2100042202. Country Barn, Coffee Creamer, Non-Dairy creamer, Net WT/Peso Neto 6 oz ( 170g), SKU 3540603606. Country Barn, Coffee Creamer, Non-Dairy creamer, Net WT/Peso Neto 11 oz ( 312g), SKU 3540603611. Libby's Coffee Creamer, Non-Dairy creamer, 16 oz (544 g) SKU 1614308012. Libby's Coffee Creamer, Non-Dairy creamer, 22 oz SKU 1614308013. Libby's Coffee Creamer, Non-Dairy creamer, 35.3 oz SKU 1614308014. Golden Flag, Non Dairy Creamer, Net WT 22 oz (1 lb 6 oz) 624 g, SKU 6464410734. 515595601 513595604 520595602 513595603 515595604 521595602 Class II Kerry, Inc. is voluntarily recalling all Nondairy Creamer produced between May 12, 2015 and May 28, 2015 due to the potential for a few packages to contain small pieces of metal from a broken screen on the production line. Kerry Foods
Food Kraft French Vanilla, Creamer, Non-Dairy Creamer, Net WT/Contenido Neto 35.3 oz (1 kg) SKU 2100002971. Publix, Nondairy, FrenchVanilla, Naturally and Artificially Flavored Coffee Creamer, Net Wt 15 oz (425 g), SKU 4141501625. 515595606 522595602 Class II Kerry, Inc. is voluntarily recalling all Nondairy Creamer produced between May 12, 2015 and May 28, 2015 due to the potential for a few packages to contain small pieces of metal from a broken screen on the production line. Kerry Foods
Devices TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions. Part # 04.004.000, lot # 7950994 Class II A specific part and lot number were packaged and shipped prior to the completion of a required internal inspection. The nonconformance is not expected to pose an additional health risk to the patient or user if the device was used. No adverse events reported. Synthes, Inc.
Devices Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) Class II The Primus that includes the optional Chop / Lift Bar. There is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall. BTE is voluntarily processing a field correction to eliminate this risk. BTE Technologies, Inc.
Devices Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163. All products in the Lava Ultimate product family. Class II 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers. 3M Company - Health Care Business
Devices Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis. Lot numbers SM59161 and SM60278 Class II Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation. Alliance Partners LLC
Food Garden Fresh Steakhouse Potato Salad Kit, CODE#1076, NET WT 10.75 LBS (4.876 KG) , UPC 0 01 11596 51076 4. 070615 (PO 78432885) Class I Garden Fresh Foods, Inc. reported one case of Steakhouse Potato Salad Kit tested presumptive for Listeria monocytogenes. Garden-Fresh Foods, Inc.
Devices Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated. Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019 Class II RTI Surgical Inc. (RTI) Doing business as Pioneeer Surgical Technology is conducting a voluntary recall on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile which is distributed by DePuy Spine Inc. It has been identified that the box end label is incorrectly labeled as "Titanium" instead of "Stainless Steel". RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Devices A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself. Class II Biomet initiated this action following an investigation which identified that the thread location, on one of the thread holes, is offset from the axis of the predill hole; therefore, the threads are too deep on one side and too shallow on the other. This issue may present the following risks: If the locking screw does not achieve proper purchase, the screw may back out of the plate. This may require a revision surgery to replace or remove the screw and/or plate. Due to the threads not being uniformly loaded, as designed; they may shear off, causing metal slivers. This may cause soft tissue irritation. Biomet, Inc.
Food Champ's Sliced Crimini Mushrooms, net weight 227 gram (8 oz), UPC 6 78286 88877 5. The product's label is read in parts: "***Champ's Mushrooms***Sliced Crimini Mushrooms***KEEP REFRIGERATED***Product of Canada***Aldergrove. B.C V4W 2Z6***". none Class I Champ's Sliced Crimini Mushrooms, product of Canada, are recalled due to the potential to be contaminated with Listeria monocytogenes United Salad Company
Food Redwood Hill Farm Raw Milk Feta; Artisan Goat Cheese; Perishable, keep refrigerated. Ingredients: Raw goat milk, sea salt, Vegetarian enzyme, cultures. Packaged in a 3 lb. plastic bucket (in brine), Two buckets per case. Handmade in Sebastopol, CA Redwood Hill Farm & Creamery, Sebastopol, CA Lot # 14000610 Class I One lot of Raw Milk Goat Cheese tested positive for Listeria monocytogenes. Redwood Hill Farm
Drugs Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot #: 131924, Exp 07/31/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 131954, 131955, Exp 08/31/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 131953, Exp 07/31/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 134419A, Exp 12/31/2015; Lot#: 193441B, Exp 02/29/2016; Lot#: 133684B, Exp 09/30/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 134420, 142540, Exp 7/31/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 134392, Exp 06/30/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 132323, Exp 07/31/2015; Lot#: 132960, Exp 09/30/2015; Lot#: 133707A, Exp 10/31/2015; Lot#: 133707B, Exp 11/30/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 132146, Exp 06/30/2015; Lot#: 132147, 132963, Exp 08/31/2015; Lot#: 132964, Exp 10/31/2015; Lot#: 134319, Exp 12/31/2015; Lot#: 134320, Exp 01/31/2016. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 131928, Exp 09/30/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 131933, Exp 07/31/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 131934, Exp 09/30/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 131935, Exp 08/31/2015 Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Drugs Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A Exp Date: 07/31/2016 & Lot#: 134418B Exp Date: 07/31/2016. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. American Health Packaging
Biologics Cornea 20150083OD; 20150083OS Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. International Sight Restoration, Inc.
Drugs Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6. Lot #: 3053562, Exp 02/16 Class II Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. Mylan Pharmaceuticals Inc
Drugs Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12 Lot #: 4D040, Exp 4/2016 Class III Subpotent Drug: menthol and methyl salicylate below specification BioComp Pharma, Inc.
Drugs CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31 Lot #: 04012015@45, Expiry: 09/28/2015 Class III Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Abrams Royal Pharmacy II, LLC
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