FDA-Drug2023-12-20Class II

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

Lupin Pharmaceuticals Inc.
Hazard

Failed Dissolution Specifications

Sold states
Product was distributed to 3 wholesale/distributor accounts.
Affected count
N/A
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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

Official notice

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

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