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
Reported: November 28, 2018 Initiated: November 7, 2018 #D-0283-2019
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 4,212 (30-count blister pack)
- Distribution
- U.S.A.nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 4,212 (30-count blister pack).
Why was this product recalled? ▼
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 28, 2018. Severity: Moderate. Recall number: D-0283-2019.
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