PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 21, 2019 Initiated: July 24, 2019 #D-1723-2019

Product Description

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

Details

Recalling Firm
Alvogen, Inc
Units Affected
4272 bottles
Distribution
Natonwide, PR
Location
Pine Brook, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Alvogen, Inc. Units affected: 4272 bottles.
Why was this product recalled?
Failed dissolution specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1723-2019.