Reported Dec 19, 2018 · Terminated
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- 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
- Lot codes and dates
Lot #: T700423Exp 08/2019T800310Exp 03/2020
- Amount recalled
- 4,404 (30 count blister packs)
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.
This product could cause temporary or reversible health problems — stop using it.
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