FDA recall D-0148-2024

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 for recall

Failed Dissolution Specifications

Distribution

Product was distributed to 3 wholesale/distributor accounts.

Key facts

Status

Terminated

Initiation date

2023-11-22

Report date

2023-12-20

Termination date

2024-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0148-2024