August 2018 FDA Recall Lisinopril by Lupin Pharmaceuticals Inc.
D-1077-2018 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on August 13, 2018 for the product Lisinopril. The FDA reported the reason for recall as presence of foreign substance. The product was distributed in Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States. and the recall is currently terminated.
Recall Number: D-1077-2018
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
08-13-2018
08-22-2018
11,706 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 distributors, mail order pharmacy and supermarkets throughout the United States.
10-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Batch or Lot Expiration Information
Lot# : H800414, Exp. 12/2019
