FDA recall D-1302-2014

Blu Pharmaceuticals Inc · Class II · drug

Product

Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05

Reason for recall

Defective container: Product distributed without inner seal on bottles.

Distribution

NJ, UT, IL and CT

Key facts

Status: Terminated
Initiation date: 2014-03-13
Report date: 2014-05-14
Termination date: 2015-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Franklin, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1302-2014