Class I - Dangerous
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class I - Dangerous
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class I - Dangerous
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Class I - Dangerous
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP deviations: Product bottle may be absent of desiccant.
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Class I - Dangerous
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class I - Dangerous
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
Zydus Pharmaceuticals USA
Class I - Dangerous
cGMP Deviations
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP deviations: Product bottle may be absent of desiccant.
Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11
American Health Packaging
Class I - Dangerous
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.