FDA recall D-0283-2019

Product

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

Reason for recall

Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.

Distribution

U.S.A.nationwide

Key facts

Status

Terminated

Initiation date

2018-11-07

Report date

2018-11-28

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0283-2019