Drug product
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02
D-1581-2019
Product summary
- Event
- Event 83363
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,832 bottles
- Official record key
drug-enforcement:D-1581-2019
Official wording
Reason: Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Code information: Lot #:H801815, Exp. March 2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets