FDAFDA · Food and drugs·Recall number D-0294-2019
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 December 19, 2018 · Recall initiated: December 10, 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 -Two additional lots being recalled due to Out-of-Specification results 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
- Product was distributed to 4 major distributors who distributed the product throughout the United States.
- Lot
- Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.