September 2022 FDA Recall Lisinopril by Lupin Pharmaceuticals Inc.
D-1536-2022 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on September 13, 2022 for the product Lisinopril. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1536-2022
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
09-13-2022
09-21-2022
11,802 1000-count 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 major distributors/wholesalers nationwide.
01-31-2024
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, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Batch or Lot Expiration Information
Lot# Q201182, exp. date March 2024
