PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 31, 2019 Initiated: July 19, 2019 #D-1581-2019

Product Description

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.

Details

Units Affected
11,832 bottles
Distribution
Nationwide within the United States
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 11,832 bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1581-2019.