Why it was recalled
Failed Dissolution Specifications
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
Lot numbers, UPCs & expiration codes
Lot # M200498, Exp. June 2024
Where it was sold
Product was distributed to 3 wholesale/distributor accounts.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0148-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 22, 2023
- FDA report date
- Dec 20, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0148-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 93482
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # M200498, Exp. June 2024
- Postal code
- 21202-6174
- Report date
- Dec 20, 2023
- Product type
- Drugs
- Recall number
- D-0148-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Termination date
- Jul 8, 2024
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 3 wholesale/distributor accounts.
- Recall initiation date
- Nov 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 13, 2023