Class II
Terminated
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
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- December 10, 2018
- Posted
- December 19, 2018
- Recall Number
- D-0294-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,404 (30 count blister packs)
- Firm Location
- Princeton, NJ, United States
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.
Lot / Code Info
Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
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