Drug Enforcement D-0148-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class II

Report Date

December 20, 2023

Termination Date

July 8, 2024

Product Information

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
Product quantity
N/A
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed to 3 wholesale/distributor accounts.

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
Harborplace Tower, 111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0148-2024
Event ID
93482
Recall initiation date
November 22, 2023
Center classification date
December 13, 2023
Code info
Lot # M200498, Exp. June 2024
More code info
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