Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
Avkare Incorporated
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
Avkare Incorporated
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Supterpotent Drug
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Pharmcore
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
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class I - Dangerous
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.
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.
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Baxter Healthcare
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Lack of assurance of sterility.
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
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Validus Pharmaceuticals
Class I - Dangerous
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
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
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class I - Dangerous
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.