June 2023 FDA Recall Amlodipine Besylate by Lupin Pharmaceuticals Inc.
D-0899-2023 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on June 27, 2023 for the product Amlodipine Besylate. The FDA reported the reason for recall as subpotent drug. The product was distributed in Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States. and the recall is currently terminated.
Recall Number: D-0899-2023
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
06-27-2023
07-19-2023
3,096 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
03-12-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : A102887, Exp. 6/2023
