Amlodipine Besylate Tablets recall: Subpotent
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S…
Why was Amlodipine Besylate Tablets recalled?
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: A102887, Exp. 6/2023
- Product
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 3,096 bottles
- Distribution
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
- Recall date
- July 19, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)