April 2020 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-1250-2020 - Product Mix-Up

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on April 20, 2020 for the product Drug. 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-1250-2020

Reason for Recall
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Initiated
04-20-2020
Reported
04-29-2020
Quantity
11,808 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85511
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed Nationwide in the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2021
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03

Batch or Lot Expiration Information

Lot# Q000255, Exp 01/2022