April 2020 FDA Recall Lisinopril by Lupin Pharmaceuticals Inc.
D-1079-2020 - Presence of Foreign Tablet/ Capsule
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on April 1, 2020 for the product Lisinopril. The FDA reported the reason for recall as presence of foreign tablet/ capsule. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1079-2020
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
04-01-2020
04-08-2020
25,944 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.
U.S.A. Nationwide
06-30-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
Batch or Lot Expiration Information
Lot# : Q900580, Exp 9/2021
