Dr. Reddy's Laboratories, Inc. recalls Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laborat…
- Recall date
- December 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0294-2019
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Product was distributed to 4 major distributors who distributed the product throughout the United States.
Why it was recalled
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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