FDA-Drug2018-11-28Class II

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

Dr. Reddy's Laboratories, Inc.
Hazard

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

Sold states
U.S.A.nationwide
Affected count
4,212 (30-count blister pack)
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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

Official notice

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

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