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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Event Detail

Event ID 67723
Product Type Drugs
Status Ongoing
Recalling Firm Terra-Medica Inc.
City Ferndale
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-03
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1. Batch # 23109; EXP: September 2014; Batch # 08030; EXP: February 2015; Batch # 12032; EXP: February 2017; Batch # 26043; EXP: March 2018. Class II Penicillin Cross Contamination 8405 bottles D-1207-2014
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2. 10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. Class II Penicillin Cross Contamination. 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons D-1206-2014
Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1. Batch # 24030; EXP: February 2015; Batch # 14062; EXP: May 2017. Class II Penicillin Cross Contamination 4050 cartons D-1205-2014
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1. Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017. Class II Penicillin Cross Contamination 2147 cartons D-1204-2014
Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2. 10 x 1 ml: Batch # 13090; EXP: August 2015. 50 x 1 ml: Batch #13090, EXP: August 2015. Class II Penicillin Cross Contamination 211 10 x 1 ml vials; 152 50 x 1 vials D-1203-2014
Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1. Batch # 15129; EXP: November 2014; Batch #12040, EXP: March 2015; Batch #01081, EXP: August 2016. Class II Penicillin Cross Contamination 10,725 bottles D-1202-2014
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1. Batch # 25030; EXP: April 2015; Batch # 27101, EXP: Sept 2016. Class II Penicillin Cross Contamination 3066 cartons D-1201-2014
Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1. Batch # 2089; EXP: June 2014; Batch #3031 , EXP: June 2016. Class II Penicillin Cross Contamination 3725 cartons D-1200-2014
Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1. Batch #04062 , EXP: May 2017; Batch #06062 , EXP: May 2017. Class II Penicillin Cross Contamination 6120 cartons D-1199-2014
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1. Batch # 08060; EXP: May 2015; Batch # 07119, EXP: August 2014; Batch # 03043, EXP: May 2018. Class II Penicillin Cross Contamination 428 bottles D-1212-2014
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2. 10 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. Class II Penicillin Cross Contamination 111 10 x 1 mls; 39 50 x 1 mls D-1211-2014
Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2. (10 x 1 mL) Portable Sips: Batch # 20010, EXP: December 2014. (50 x 1ml) Portable Sips: Batch # 20010, EXP: December 2014. Class II Penicillin Cross Contamination 32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons D-1198-2014
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1. Batch # 07011; EXP: December 2015; Batch # 09043, EXP: March 2108. Class II Penicillin Cross Contamination 3440 bottles D-1210-2014
Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1. Batch # 2011; EXP: December 2015; Batch # 2081, EXP: July 2016; Batch # 3063, EXP: May 2018; Batch # 1013, EXP: February 2018. Class II Penicillin Cross Contamination 5940 Packages D-1209-2014
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 . (10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015. Class II Penicillin Cross Contamination 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons D-1197-2014
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1. Batch # 27100; EXP: September 2015; Batch # 29100; EXP: October 2015; Batch # 25013; EXP: January 2018. Class II Penicillin Cross Contamination 4770 Cartons D-1208-2014
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2. (10 x 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018. Class II Penicillin Cross Contamination 730 10 x 1mL Cartons; 367 50 x 1 mL Cartons D-1196-2014
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1. Batch # 21049, EXP: March 2014; Batch # 13059; EXP: April 2014; Batch # 09080, EXP: July 2015; Batch #15100; EXP: September 2015; Batch # 24092; EXP: August 2017. Class II Penicillin Cross Contamination 21,445 Bottles D-1195-2014
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1. Batch # 15070, EXP: June 2015; Batch # 24072, EXP: June 2017. Class II Penicillin Cross Contamination 4955 cartons D-1194-2014
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1. Batch # 14010, EXP: December 2014; Batch # 11080, EXP: August 2015; Batch # 12092, EXP: July 2017. Class II Penicillin Cross Contamination 7408 cartons D-1193-2014
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1. Batch # 1080, EXP: July 2015; Batch # 1102, EXP: Septempber 2017. Class II Penicillin Cross Contamination 4860 cartons D-1192-2014
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1. Batch # 03051, EXP: April 2014; Batch # 13072, EXP: June 2015; Batch #21033, EXP: April 2016. Class II Penicillin Cross Contamination 1368 tubes D-1191-2014
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