Class I - Dangerous
Failed Impurities/Degradation Specifications
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Prescription Drugs
💊 Drugs • 12,141 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
Class I - Dangerous
Subpotent and Superpotent Drug
Class I - Dangerous
Superpotent Drug and Subpotent Drug: potency failures obtained
Class I - Dangerous
Subpotent and Superpotent Drug
Class I - Dangerous
Subpotent and Superpotent Drug
Class I - Dangerous
Subpotent and Superpotent Drug
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).