Drug product
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
D-0532-2025
Product summary
- Event
- Event 97118
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58,968 bottles
- Official record key
drug-enforcement:D-0532-2025
Official wording
Reason: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Code information: Lot #: QA01081, Exp. Date April 2027
Distribution pattern: Product was distributed nationwide within the United States.
Derived failure modes
-
Foreign material or chemical contamination
foreign tablet