Product: Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated: 20210315
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated