Quinapril Tablet
FDA Recall NDC 68180-554
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Quinapril (NDC 68180-554). A significant event, classified as Class II, was initiated on Dec 07, 2022 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Dec 07, 2022
Dec 28, 2022
23,736
Recall Profile & Regulatory Data
Event ID
91279
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed by major distribution chains nationwide.
Termination Date
Aug 01, 2024
Product Description
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
68180-556-09Product
68180-557-09Product
68180-557-03Product
68180-558-09Product
68180-558-03Product
68180-554-09Product
68180-554-03Product
68180-559-03Product
68180-559-09Product
Class II Terminated
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Dec 07, 2022
Dec 28, 2022
30,612 bottles
Recall Profile & Regulatory Data
Event ID
91279
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed by major distribution chains nationwide.
Termination Date
Aug 01, 2024
Product Description
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
Affected Packages Involved in this Recall
68180-556-09Product
68180-557-09Product
68180-557-03Product
68180-558-09Product
68180-558-03Product
68180-554-09Product
68180-554-03Product
68180-559-03Product
68180-559-09Product
December 2015 Class III Recall: Failed Impurities/Degradation Specifications; Impurity A
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications; Impurity A
Dec 07, 2015
Apr 12, 2017
15,168 bottes
Recall Profile & Regulatory Data
Event ID
76924
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 10, 2017
Product Description
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Batch or Lot Expiration Information
Batch# Batch number G303703, exp 3/2016
Affected Packages Involved in this Recall
68180-556-09Product
68180-557-09Product
68180-557-03Product
68180-558-09Product
68180-558-03Product
68180-554-09Product
68180-554-03Product
68180-559-03Product
68180-559-09Product
September 2013 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Sep 17, 2013
Jan 22, 2014
22, 896 bottles
Recall Profile & Regulatory Data
Event ID
66345
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 11, 2016
Product Description
Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09
Batch or Lot Expiration Information
Lot# Lot 3110358 Exp. 12/13
Affected Packages Involved in this Recall
68180-556-09Product
68180-557-09Product
68180-557-03Product
68180-558-09Product
68180-558-03Product
68180-554-09Product
68180-554-03Product
68180-559-03Product
68180-559-09Product
September 2013 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Sep 17, 2013
Jan 22, 2014
30,264 bottles
Recall Profile & Regulatory Data
Event ID
66345
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 11, 2016
Product Description
Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09
Batch or Lot Expiration Information
Lot# Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
Affected Packages Involved in this Recall
68180-556-09Product
68180-557-09Product
68180-557-03Product
68180-558-09Product
68180-558-03Product
68180-554-09Product
68180-554-03Product
68180-559-03Product
68180-559-09Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
