September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
Mayne Pharma Inc recalls Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenv
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
September 5, 2018DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338
Hazard: CGMP Deviations
September 5, 2018DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-
Hazard: Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
September 5, 2018DrugsFDA
Living Well Remedies, LLC recalls Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin
Hazard: Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
August 29, 2018DrugsFDA
Westminster Pharmaceuticals LLC recalls Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: W
Hazard: 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.
August 29, 2018DrugsFDA
Westminster Pharmaceuticals LLC recalls Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for:
Hazard: 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.
August 29, 2018DrugsFDA
Westminster Pharmaceuticals LLC recalls Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for:
Hazard: 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.
August 29, 2018DrugsFDA
Westminster Pharmaceuticals LLC recalls Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured f
Hazard: 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.
August 29, 2018DrugsFDA
Westminster Pharmaceuticals LLC recalls Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: We
Hazard: 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.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceutic
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceutica
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmac
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceutical
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Onl
Hazard: Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
August 29, 2018DrugsFDA
A-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Onl
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
A-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx O
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
A-S Medication Solutions LLC. recalls Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
A-S Medication Solutions LLC. recalls Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejian
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Preferred Pharmaceuticals, Inc recalls Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, M
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, M
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Ma
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Ma
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 22, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Orexigen Therapeutics, Inc. recalls Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed
Hazard: Defective Container: Customer complaints of punctures in the bottle.
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC:
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC:
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.