Drug product
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09
D-0092-2018
Product summary
- Firm
- Lupin Limited
- Event
- Event 78566
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0092-2018
Official wording
Reason: Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Code information: Lot # G702459, Exp 2/20
Distribution pattern: Product was distributed throughout the United States, including Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets