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

FDA recall notice · announced July 31, 2019 · Lupin Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #:H801815, Exp. March 2021
Quantity: 11,832 bottles
Status: Terminated
Products in this recall event:
- 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 Pitham (D-1581-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.