Recalls / Class II
Class IID-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
- Brand name
- Penicillamine
- Generic name
- Penicillamine
- Active ingredient
- Penicillamine
- Route
- Oral
- NDC
- 70748-153
- FDA application
- ANDA212933
- Affected lot / code info
- Lot # M200498, Exp. June 2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed to 3 wholesale/distributor accounts.
Timeline
- Recall initiated
- 2023-11-22
- FDA classified
- 2023-12-13
- Posted by FDA
- 2023-12-20
- Terminated
- 2024-07-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0148-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.