Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03
L. Perrigo Company
Failed Impurities/Degradation Specifications
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L. Perrigo Company
Failed Impurities/Degradation Specifications
B. Braun Medical
Lack of assurance of sterility: bags have the potential to leak.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
L. Perrigo Company
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Failed Stability Specifications
Amerisource Health Services
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Packaging defect: blister packaging inadequately sealed.
Homeocare Laboratories
cGMP deviations
SUN PHARMACEUTICAL INDUSTRIES
Subpotent drug
Homeocare Laboratories
cGMP deviations
Homeocare Laboratories
cGMP deviations
Homeocare Laboratories
cGMP deviations
Homeocare Laboratories
cGMP deviations
The Harvard Drug Group LLC
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Failed Impurities/Degradation Specifications
Amneal Pharmaceuticals of New York
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Amring Pharmaceuticals
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.