July 2020 FDA Recall Lisinopril by Lupin Pharmaceuticals Inc.
D-1413-2020 - Presence of Foreign Tablets/Capsules
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on July 17, 2020 for the product Lisinopril. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in Product was distributed to OH and may have been further distributed throughout the United States. and the recall is currently terminated.
Recall Number: D-1413-2020
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
07-17-2020
08-05-2020
11,688 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 OH and may have been further distributed throughout the United States.
08-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Batch or Lot Expiration Information
Lot# Q000232, exp. date 01/2022
