D-0283-2019 Class II Terminated
FDA drug recall D-0283-2019 was initiated by Dr. Reddy's Laboratories, Inc. on Nov 7, 2018 and is designated Class II. Reason for recall: Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing. The recall status is terminated (terminated May 19, 2020). Affected quantity: 4,212 (30-count blister pack).
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 28, 2018
- Initiation Date
- Nov 7, 2018
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,212 (30-count blister pack)
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: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Distribution Pattern
U.S.A.nationwide
Code Information
Lot #: T600530, Exp 11/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0283-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026