D-0294-2019 Class II Terminated
FDA drug recall D-0294-2019 was initiated by Dr. Reddy's Laboratories, Inc. on Dec 10, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jun 25, 2020). Affected quantity: 4,404 (30 count blister packs).
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 19, 2018
- Initiation Date
- Dec 10, 2018
- Termination Date
- Jun 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,404 (30 count blister packs)
Product Description
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 Pattern
Product was distributed to 4 major distributors who distributed the product throughout the United States.
Code Information
Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0294-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026