Recall: D-0148-2024

Class II - Potentially Harmful

Class IIClassification

2023-11-22Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Reason

Failed Dissolution Specifications

Distribution

Product was distributed to 3 wholesale/distributor accounts.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.