Drug 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.
Lots and codes
Lot #: T600530, Exp 11/18
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 4,212 (30-count blister pack)
- Distribution
- U.S.A.nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 7, 2018
- Terminated
- May 19, 2020
Related products
- Clopidogrel bisulfate – drug information
- NDC 55111-671 Clopidogrel bisulfate · Clopidogrel Bisulfate 300 mg/1 · Dr.Reddy's Laboratories Limited