FDARecalled Jul 19, 2023 · #D-0899-2023
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 ...
Hazard
Class III — low health risk
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Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. Classification: Class III Distribution: Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Product details
- Product
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
- Type
- Drugs
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Model numbers
- A102887
- UPCs
- —