• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of August 6, 2014

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 107188134 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Systems, Inc.
Food MAX Brand BRAZILIAN BEE PROPOLIS, 180 Count Softgels Product labeling reads in part:"MAX***BRAZILIAN BEE PROPOLIS DIETARY SUPPLEMENT 180 Softgels***6 65176 31465 0***Manufactured For:HealthMax Products Co. Altadena, CA 91001***". Lot # BP0417 UPC 6 65176 31465 0 Class III In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. Healthmaxx Global Inc.
Drugs Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 all lot codes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. all lot codes, .25 oz and 2 oz sizes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008. all lot codes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002. all lot codes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068. all lot codes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019 all lot codes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005 all lot codes Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007. all lot codes 30 ml and 50 ml Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively. all lot codes 30 ml and 50 ml Class II Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Dermamedics, L.L.C.
Drugs triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78 35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15. Class II Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole. Teva Pharmaceuticals USA
Food Original Silk Light Soymilk Half Gallon, Distributed by WhiteWave Foods Broomfield, Colorado 80021, UPC 0 25293 60101 7 Use by dates of 06/22/14 and 06/23/14 will be found on the carton's gable top. 06/22 or 23/14 hh:mm 48-0994 EH3-5 1; 06/22 or 23/14 hh:mm 48-0994 EH3-5 2; 06/22 or 23/14 hh:mm 48-0994 EH3-4 3; and 06/22 or 23/14 hh:mm 48-0994 EH3-4 4. Code breakdown as follows: 6/22/14 and 6/23/14 are the expiration dates; hh:mm  ...
More
Class I The product has the potential to contain undeclared almondmilk. White Wave Foods, Inc
Devices Dimension® Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX Class III There is a misassembly issue with the photometer installed on Dimension® Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells Leukocytes Reduced W088414514645 Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Blood Bank Of Hawaii
Devices Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones. All lots Class II Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU. Small Bone Innovations
Biologics Platelets Pheresis Leukocytes Reduced W072114000066 Class II Blood products, which did not meet the acceptable product specifications for release, were distributed. Southern California Permanente Medical Group
Devices InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156. Model 2130 T01168 T01723 T01331 T02213 T02554 T01544 T01167 T01722 T01330 T02212 T02553 T01609 T01166 T01721 T01329 T02211 T02552 T01608 T01165 T01310 T01328 T02210 T02551 T01543 T01164 T02089 T01327 T02209 T02550 T02515 T01163 T01967 T01326 T02208 T02549 T02514 T01162 T01966 T01325 T02207 T02173 T02513 T01161 T01965 T01324 T02206 T02172 T01613  ...
More
Class II Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affected by having a reduced holding force Stryker Medical Division of Stryker Corporation
Food Professional Bak-klene All Purpose No-Stick Bakery Spray, packaged in 14-oz. aerosol cans. 4135 1 CAKE 1800 thru 2100 (1800-2100 = military times affected) Class II The product contains undeclared wheat. Plaze Inc
Devices IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing. Lot #3P3446 Class I Potential for microbial contamination of the product. Wellspring Pharmaceutical Corporation
Biologics Fresh Frozen Plasma W120614003490 Class III Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W120614003490 Class III Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed. Michigan Blood
Biologics Platelets Pooled Leukocytes Reduced W120614180789 Class III Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed. Michigan Blood
Biologics Red Blood Cells Leukocytes Reduced W120614330943 Class III Blood product, manufactured without the entire quantity of additive solution, was distributed. Michigan Blood
Devices Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures. Lot numbers: 082605614, 082601414, 082602014, 082634313,082630913,082629713,082629613, 082626913, 082623113,082621413,082618213 Class II Medtronic is initiating a voluntary recall for the Nexdrive® Micropositioning Drive (model Ml-1000 and Ml-2000) due to the potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth. Medtronic Neuromodulation
Drugs Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30 Lot # V130822; Exp 01/15 Class III Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. Pfizer Inc.
Drugs Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC Lot 0093943 Class III Failed Dissolution Specification; at the 12 month time interval. Mckesson Packaging Services
Devices Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures. Part Number 00-2358-014-04; lot 62276042 Class II A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole. Zimmer, Inc.
Food Richards Too Good BBQ Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. Product bears not codes. The products being recalled were distributed up to the date of June 17, 2014. Class II Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness. Richard's Rub & Seasonings, LLC
Food Richards Too Good Hot Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. Product bears not codes. The products being recalled were distributed up to the date of June 17, 2014. Class II Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness. Richard's Rub & Seasonings, LLC
Food Richards Too Good Teriyaki Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. Product bears not codes. The products being recalled were distributed up to the date of June 17, 2014. Class II Richards Rubs & Seasonings LLC is recalling Richards Too Good BBQ Sauce, Richards Too Good Hot Sauce and Richards Too Good Teriyaki Sauce because they may have been improperly processed and because they may have the potential to be contaminated with Clostridium botulinum, which can cause botulism, a serious and potentially fatal foodborne illness. Richard's Rub & Seasonings, LLC
Devices CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation. Lot Numbers 28619 & 28621 Class II "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers. Dynarex Corporation
Biologics Cryoprecipitated AHF, Pooled W20111490211; W201114902109; Class III Blood products, in which pooled cryo did not meet acceptable product specifications were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W045014904537; Class II Blood product, whose integrity was compromised during component preparation (e.g., leaking at sterile connection site), was distributed. Community Blood Center Of Gtr KC
Devices RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical. Product Code: 004660000, (Size Miller 0), Lot numbers: 1306602, 1308602 & 1310602; Product Code: 004660001, (Size Miller 1), Lot numbers: 1306612, 1308612 & 1310612; Product Code: 004660002, (Size Miller 2), Lot numbers: 1306622, 1308622, 1309622 & 1310622; Product Code: 004660003, (Size Miller 3), Lot numbers: 1306632 & 1310632; Product Code:  ...
More
Class II There is a possibility the handle of the laryngoscope may heat up and melt the end cap. Teleflex Medical
Devices PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma Serial Numbers: 40 41 99 112 114 119 124 234 237 250 251 271 272 274 276 283 299 302 306 314 315 316 319 321 323 324 325 326 329 333 337 350 351 352 356 357 358 359 360 382 383 394 396 397 398 400 402 404 405 407 409 411 414 417 418 419 420 421 423 424 428 430 431 441 450 455 457 459 460 462 463 464 465 467 471 475 476 480 482 483 484 486 488 490 491 494 495 496 497 500 505 507 509 512 516 518 519 525 526 527 528 529 531 532 533 534 535 537 538 539 541 543 546 550 552 553 554 555 556 557 559 560 561 562 563 565 566 567 570 571 572 573 574 576 579 580 582 583 585 586 588 589 591 592 593 594 595 597 598 599 600 601 602 603 604 605 606 609 610 614 615 617 622 623 624 628 629 631 632 633 635 636 637 638 639 644 645 646 647 648 649 654 655 656 657 659 661 662 663 664 665 667 668 669 672 673 674 678 682 683 684 685 686 687 688 689 690 692 694 695 697 698 699 700 702 703 705 706 707 708 709 712 713 714 715 716 717 718 719 720 721 722 901 902 903 904 905 908 909 911 912 914 915 916 917 918 921 922 923 925 926 927 928 929 930 931 932 933 935 936 938 939 940 941 942 943 944 948 949 950 951 952 954 955 956 957 958 959 960 961 962 963 964 967 968 969 970 971 972 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1014 1015 1016 1017 1018 1021 1022 1023 1024 1025 1027 1028 1029 1030 1031 1032 1034 1035 1036 1037 1039 1040 1041 305 307 327 331 386 415 425 437 443 444 445 446 447 448 540 577 578 618 619 620 621 353 454 312 322 328 330 335 346 348 349 370 381 385 387 410 510 511 515 524 558 575 608 Class II RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed. Ra Medical Systems Inc
Food Tiger-X, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Samurai-X, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Samurai Gold, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Gold, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Oyavon, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Adam, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Actimeta, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Affirm XL, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Platinum A, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Platinum B, Blister Packs No lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Ninja Mojo, small vinyl Packs LOT08152013 EXPDEC2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Single Mojo, small vinyl Packs LOT08162013 EXPDEC2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Double Mojo, small vinyl Packs LOT08172013 EXPDEC2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Ginseng Power, Blister Packs No Lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Calcium Formula, 250 cc HDPE Bottles EXP08.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Green Coffee Bean EXP08.2016 EXP10.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Shark Formula, 250 cc HDPE Bottles EXP10.2016 EXP11.2016 EXP12.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Bitter Melon, 225cc HDPE Bottle EXP10.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Chanca Piedra, 225cc HDPE Bottles EXP10.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Rinozan, 250cc HDPE Bottles EXP09.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Una De Gato, 225cc HDPE Bottle EXP12.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Saw Palmetto, Glass Bottle EXP11.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Garcinia Cambogia, 225cc HDPE Bottle EXP04.2017 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food BTI Lean Formula, 400cc HDPE Bottle LT7345 EX10.16 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food DMSA, 100cc HDPE bottle LOTKZ8010 EXP10.2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Noni Supplement, Capsules 9/23/13 > 9/30/13 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Therapeutic Care A, B, C, 225cc HDPE Bottles for A,B. Capsules for C LOTKZ1350, EXP11/2016 LOT KZ1351, EXP11/2016 LOTKZ1352, EXP11/2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Actra-SX, Vinyl Bags 11/1/13 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Maxium, Capsules; Prolong, Capsules 11/1/13 > 11/15/13 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Serrapeptase, 100cc HDPE Bottles LOTKZ1320 EXPFEB2016 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Garcinia Series, Capsules 4/9/14 > 4/12/14 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Mega Jex, Capsules 12/11/12 > 12/12/12 4/30/13 > 5/1/13 12/13/13 > 12/17/13 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Chitosan, Blister Pack 7/9/12 > 7/11/12 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Garcinia Cambogia Extract, Capsules 10/26/12 > 10/29/12 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Nano Papa 8/22/13 > 8/26/13 8/29/13 > 9/6/13 10/8/13 > 10/10/13 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Kidney&Chi Plus, Bottles 724EXP08.2015 EXP12.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Detoxification Plus, Bottles 724EXP08.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Longetivity Plus, Bottles 724EXP08.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Stomach & Spleen Plus, Bottles 819EXP08.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Bone & Joint Plus, Bottles 819EXP08.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Circulation and Energy Formula, Bottles EXPFEB2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Tendon & Muscle Plus, Bottles 509EXP05.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Vital Balance Formula, Bottles EXP12.2015 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Via-Max Gold, Blister packs No Lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Albert, Capsules 3/6/12 > 3/8/12 6/1/12 > 6/4/12 8/3/12 > 8/3/12 9/6/12 > 9/6/12 9/21/12 > 9/28/12 10/16/12 > 10/16/12 11/8/12 > 11/8/12 11/29/12 > 11/29/12 Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food CKLS, Capsules No Lot numbers Class II GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements. GM Manufacturing Inc.
Food Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***market pantry Apple Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***" UPC Code: 0-85239-20507-5 BEST BY 19 FEB 2015 through BEST BY 28 MAY 2015 Class II Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold. PUREFRUIT CHILE S.A
Food Market Pantry Apple Cinnamon; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***market pantry Apple Cinnamon Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***" UPC Code: 0-85239-20508-2 BEST BY 22 FEB 2015 through BEST BY 30 MAY 2015 Class II Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold. PUREFRUIT CHILE S.A
Food fruty U applesauce, apple; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Chile***" UPC Code: 7804636770367 26 FEB 2015 through 30 APR 2015 Class II Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold. PUREFRUIT CHILE S.A
Food fruty U applesauce, apple cinnamon; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE CINNAMON applesauce***NET WEIGHT 3.53 OZ***FRUTY U www.frutyu.com Product of Chile***" UPC Code: 7804636770374 23 FEB 2015 through 26 APR 2015 Class II Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold. PUREFRUIT CHILE S.A
Food HyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, "***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266 PRODUCT OF CHILE***" UPC Code: 075450082029 Best By: NOV 12 2014 Class II Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold. PUREFRUIT CHILE S.A
Food Malt-O-Meal Frosted Flakes, item number 00955, UPC 42400-00955. Net Wt. 2.00oz (56g) Lot Code on Bowl: FEB1215M2P Class III Malt-O-Meal Sugar Frosted Flakes Bowls for foodservice may contain Honey and Oat Blenders and are therefore mislabeled. mom Brands
Food Whole Foods Caesar Salad Mini Net Wt 4 0z plastic shell Sell By 7/11/14 Class II Product labels switched and undeclared allergens not declared in ingredient statement. Caesar salad contains undeclared tree nuts and Goat Cheese salad undeclared fish Whole Foods Market Group Inc.
Food Whole Foods Mesclun Goat Cheese Salad Mini Net Wt 4 0z plastic shell Sell By 7/11/14 Class I Product labels switched and undeclared allergens not declared in ingredient statement. Caesar salad contains undeclared tree nuts and Goat Cheese salad undeclared fish Whole Foods Market Group Inc.
Food SEQUATCHIE COVE CREAMERY, CUMBERLAND (cheese), 320 DIXON COVE ROAD, SEQUATCHIE, TN 37374 Lot # 93 Class II Sample of cheese taken by FDA was found to contain generic E Coli. Ledgendairy Cheeseworks, LLC DBA Sequatchie Cove Creamery
Devices Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2. Software Versions: 2.0.0, 2.0.1, and 2.0.2 Class II The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to be displayed. For non-square pixels, the pixel width x is different to the pixel height y. Due to a software error in PDM 2.0, the x and y values are swapped, leading to the result that each individual pixel appears rotated by 90 degrees. This results in a distorted display of the image data. The magnitude of distortion may vary, depending on the Pixel Aspect Ratio, the ratio of width and height of a pixel. Accordingly, for some cases the data distortion will be clearly visible on the Brainlab planning or navigation system, e.g. during the review of the data or when performing the initial patient registration. However, if a non-obvious distortion would occur and not be detected during review of the data, the deviation of the information displayed in the planning or navigation software could mislead the user regarding clinical decisions. 2) It has been determined that non-square pixel data is not suitable for dose calculation with the current Brainlab iPlan RT systems. The actual delivered treatment dose might be different from the dose shown in the treatment plan. Brainlab AG
Devices DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc. Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363 Class II The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira. DeRoyal Industries Inc
Devices DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541 Class II The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira. DeRoyal Industries Inc
Devices Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. Product Code: 004434400, Lot number: 02A1402138 Class II Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades. Teleflex Medical
Devices MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651. Class II Laser aperture label was not affixed to device prior to shipment in the US. Nidek Inc
Drugs Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90 Lot #14P0292, Exp 04/2016 Class II Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. Jubilant Cadista Pharmaceuticals Inc.
Devices FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare. Lot Number SPSGT14-02B0027a SPSGT14-04D0005 SPSGT14-04D0023 SPSGT13-10J0016 SPSGT13-11K0041 SPSGT13-12L0008 SPSGT14-01A0009 SPSGT14-02B0026 SPSGT14-04D0015 SPSGT14-04D0026 SPSGT13-10J0017 SPSGT13-11K0039 SPSGT13-11K0042 SPSGT13-12L0015 SPSGT14-01A0028 SPSGT14-02B0028 SPSGT14-02B0033 SPSGT14-04D0014 SPSGT14-04D0027 SPSGT14-05E0005 SPSGT13-10J0018 SPSGT13-11K0040 SPSGT13-12L0007 SPSGT13-12L0012 SPSGT14-01A0027 Part No. 5151-01200-010 5151-01200-010 5151-01200-010 5151-01200-011 5151-01200-011 5151-01200-011 5151-01200-011 5151-01250-010 5151-01250-010 5151-01250-010 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01250-011 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-010 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 5151-01300-011 Class II Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored. Baxter Healthcare Corporation
Drugs Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30 Lot #213655B Exp - 12/31/2014 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development
Drugs Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90 30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 Exp - 12/31/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development
Drugs Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30 Lot #0002106 Exp - 11/30/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development
Drugs Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30 Lot #211836 Exp - 11/30/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development
Drugs Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18 Lot NVWG Exp - 11/30/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Daiichi Sankyo Pharma Development
Drugs Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90 30 count - Lot #0002096 Exp - 12/31/2016; 90 count - Lot #0002058 Exp -12/31/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Daiichi Sankyo Pharma Development
Drugs Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30 Lot #0002073 Exp - 12/31/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Daiichi Sankyo Pharma Development
Drugs Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90 30 count/Lot #0002073 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016 Class II Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Daiichi Sankyo Pharma Development
Devices Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015. Class II Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Novocol, Inc.
Devices Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert. Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015. Class II Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Novocol, Inc.
Devices Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0 Class II The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. Mckesson Medical Immaging
Food King of Pops Key Lime Pie, frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405 UPC codes: 59959 00305 and 59959 00304 Class II Undeclared Allergens: Soy, Wheat Coastal KOP LLC dba King of Pops
Food King of Pops Banana Puddin', frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405 UPC codes: 59959 00305 and 59959 00304 Class II Undeclared Allergens: Soy, Wheat Coastal KOP LLC dba King of Pops
Drugs OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41. Lot #: 360241A, Expiry: 05/2015. Class III Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Boehringer Ingelheim Roxane Inc
Drugs Fagron, Phytobase Cream, 500 g, RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6. Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15 Class II Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. Fagron, Inc
Drugs Fagron, Pentravan Base 2.5 Kg, RX only, For prescription compouning, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8. Lot # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17 Class II Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. Fagron, Inc
Drugs Fagron, Pentravan Plus Base 2.5 Kg, RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Preserved and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8, Lot # 14C03-U09-017846; Exp. 03/17 Lot # 14B28-U06-017824; Exp. 03/17 Class II Microbial Contamination of Non-Sterile Products: Fragon is recalling six lots due to the presence of mold. Fagron, Inc
Drugs Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10 Lot EJ9591 Class II Presence of Foreign Substance; tablets may contain stainless steel metal particulates Sandoz Incorporated
Show all Code Info
-
-