Superpotent Drug and Subpotent Drug: potency failures obtained
All Recalls
95,114 total recalls in our database
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
CGMP Deviations: Released product should have been rejected.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
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
Failed Impurities/Degradation Specifications
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
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
cGMP Deviations: Temperature excursion