FDAFDA · Food and drugs·Recall number 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 India, NDC 68180-721-03
Published July 19, 2023 · Recall initiated: June 27, 2023
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
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
- UPC
- 0368180233022
- Lot
- Lot #: A102887, Exp. 6/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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