May 2020 FDA Recall Lisinopril by Lupin Pharmaceuticals Inc.
D-1290-2020 - Product Mix Up
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on May 28, 2020 for the product Lisinopril. The FDA reported the reason for recall as product mix up. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1290-2020
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
05-28-2020
06-17-2020
4,224 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.
Nationwide within the US.
05-04-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
Batch or Lot Expiration Information
Lot# Q900683, Exp. 10/31/2022
