FDAFDA · Food and drugs·Recall number D-0283-2019
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
Published November 28, 2018 · Recall initiated: November 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CLOPIDOGREL BISULFATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- U.S.A.nationwide
- Lot
- Lot #: T600530, Exp 11/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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