Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01

FDA recall notice · announced August 21, 2019 · Alvogen

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01

Reason for recall

Failed dissolution specifications

Notes

Distribution: Natonwide, PR
Lot/code information: Lot # 472990, Exp 03/2020
Quantity: 4272 bottles
Status: Terminated
Products in this recall event:
- Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01 (D-1722-2019)
- Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 5242 (D-1723-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.