Multi-event December 2022 FDA Recall Quinapril by Lupin Pharmaceuticals Inc.
This Multi-event Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 7, 2022 for the product Quinapril. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0089-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
12-07-2022
12-28-2022
23,736
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 by major distribution chains nationwide.
08-01-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Batch or Lot Expiration Information
Lot# : G102929, Exp 04/2023
Affected Packages Involved in this Recall
Recall Number: D-0088-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
12-07-2022
12-28-2022
30,612 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 by major distribution chains nationwide.
08-01-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
Batch or Lot Expiration Information
Lot# : G100533, G100534, Exp. 12/2022; G203071, Exp. 03/2024
