July 2019 FDA Recall Lisinopril And Hydrochlorothiazide by Lupin Pharmaceuticals Inc.
D-1720-2019 - Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on July 17, 2019 for the product Lisinopril And Hydrochlorothiazide. The FDA reported the reason for recall as presence of foreign substance; product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.. The product was distributed in Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States. and the recall is currently terminated.
Recall Number: D-1720-2019
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
07-17-2019
08-21-2019
39,216 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
09-14-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# H900575, exp. date 01/2022
