FDA recall D-1544-2020

BAYSHORE PHARMACEUTICALS · Class II · drug

Product

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01

Reason for recall

CGMP Deviations

Distribution

nationwide

Key facts

Status
Terminated
Initiation date
2020-08-19
Report date
2020-09-02
Termination date
2021-04-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Short Hills, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1544-2020