FDA recall D-0294-2019

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 -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.

Distribution

Product was distributed to 4 major distributors who distributed the product throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-12-10

Report date

2018-12-19

Termination date

2020-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0294-2019