Drug 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
D-0148-2024
Product summary
- Event
- Event 93482
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0148-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # M200498, Exp. June 2024
Distribution pattern: Product was distributed to 3 wholesale/distributor accounts.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications