November 2023 FDA Recall Penicillamine by Lupin Pharmaceuticals Inc.
D-0148-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on November 22, 2023 for the product Penicillamine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Product was distributed to 3 wholesale/distributor accounts. and the recall is currently terminated.
Recall Number: D-0148-2024
Failed Dissolution Specifications
11-22-2023
12-20-2023
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 to 3 wholesale/distributor accounts.
07-08-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
Batch or Lot Expiration Information
Lot# M200498, Exp. June 2024
