Class III
Terminated
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
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- June 27, 2023
- Posted
- July 19, 2023
- Recall Number
- D-0899-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,096 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Distribution
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Lot / Code Info
Lot #: A102887, Exp. 6/2023
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