FDA recall D-1723-2019

Alvogen, Inc · Class II · drug

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

Distribution

Natonwide, PR

Key facts

Status: Terminated
Initiation date: 2019-07-24
Report date: 2019-08-21
Termination date: 2021-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pine Brook, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1723-2019