Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-09-05FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIDoxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged B
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
- 2018-09-05FDA-DrugLiving Well Remedies, LLCClass ILiving Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA
Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
- 2018-08-29FDA-DrugWestminster Pharmaceuticals LLCClass ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
- 2018-08-29FDA-DrugWestminster Pharmaceuticals LLCClass ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
- 2018-08-29FDA-DrugWestminster Pharmaceuticals LLCClass ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04.
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
- 2018-08-29FDA-DrugWestminster Pharmaceuticals LLCClass ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04.
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
- 2018-08-29FDA-DrugWestminster Pharmaceuticals LLCClass ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
- 2018-08-29FDA-DrugHetero Labs Limited Unit VClass IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugHetero Labs Limited Unit VClass IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugHetero Labs Limited Unit VClass IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugHetero Labs Limited Unit VClass IICamber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIIDiltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
- 2018-08-29FDA-DrugA-S Medication Solutions LLC.Class IIValsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugA-S Medication Solutions LLC.Class IIValsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugA-S Medication Solutions LLC.Class IIValsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugA-S Medication Solutions LLC.Class IIValsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugPreferred Pharmaceuticals, IncClass IIValsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-29FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- 2018-08-22FDA-DrugRemedyRepack Inc.Class IIValsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugRemedyRepack Inc.Class IIValsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugRemedyRepack Inc.Class IIValsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugOrexigen Therapeutics, Inc.Class IIIContrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.
Defective Container: Customer complaints of punctures in the bottle.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugNorthwind Pharmaceuticals LLCClass IIValsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-22FDA-DrugRanier's Compounding LaboratoryClass IIPapav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
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