D-1723-2019 Class II Terminated

Recalled by Alvogen, Inc — Pine Brook, NJ

FDA drug recall D-1723-2019 was initiated by Alvogen, Inc on July 24, 2019 and is designated Class II. Reason for recall: Failed dissolution specifications The recall status is terminated (terminated August 4, 2021). Affected quantity: 4272 bottles.

Recall Details

Product Type
Drugs
Report Date
August 21, 2019
Initiation Date
July 24, 2019
Termination Date
August 4, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4272 bottles

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

Distribution Pattern

Natonwide, PR

Code Information

Lot # 472990, Exp 03/2020