CGMP Deviations: Released product should have been rejected.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Subpotent and Superpotent Drug
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
cGMP Deviations: Temperature excursion
Class I - Dangerous
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Amerisource Health Services
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Midlab Incorporated
Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.