Reported Jul 19, 2023 · Terminated
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S
- Manufactured by
Lupin LimitedAurangabad 431 210 IndiaNDC 68180-721-03
- Lot codes and dates
Lot #: A102887Exp. 6/2023
- Amount recalled
- 3,096 bottles
Where it was sold
Why it was recalled
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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