Class I - Dangerous
Lack of assurance of sterility.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Lack of assurance of sterility.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Lack of assurance of sterility.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Auro Pharmacies
Class I - Dangerous
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class I - Dangerous
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Auro Pharmacies
Class I - Dangerous
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Levothyroxine 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.
Westminster Pharmaceuticals
Class I - Dangerous
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.
Valsartan 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
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Levothyroxine 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.
Westminster Pharmaceuticals
Class I - Dangerous
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.
Levothyroxine 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.
Westminster Pharmaceuticals
Class I - Dangerous
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.
Valsartan 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
A-S Medication Solutions
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Diltiazem 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
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Valsartan 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
A-S Medication Solutions
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Valsartan 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
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Valsartan 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
A-S Medication Solutions
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.