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Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Phar...

FDA Recall #D-0899-2023 — Class III — June 27, 2023

Recall #D-0899-2023 Date: June 27, 2023 Classification: Class III Status: Terminated

Product Description

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

Reason for Recall

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product 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.

Code Information

Lot #: A102887, Exp. 6/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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