Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceutic...
FDA Recall #D-0148-2024 — Class II — November 22, 2023
Product Description
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 for Recall
Failed Dissolution Specifications
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Product was distributed to 3 wholesale/distributor accounts.
Code Information
Lot # M200498, Exp. June 2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated