Drug product
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01
D-1720-2019
Product summary
- Event
- Event 83354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39,216 bottles
- Official record key
drug-enforcement:D-1720-2019
Official wording
Reason: Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Code information: Batch# H900575, exp. date 01/2022
Distribution pattern: Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance