Class IIQuinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-092022-12-28
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recalling firm: Lupin Pharmaceuticals Inc.
Class IIQuinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-092022-12-28
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recalling firm: Lupin Pharmaceuticals Inc.
Class IIQuinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-902022-11-02
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recalling firm: Aurobindo Pharma USA Inc.
Class IIAccupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 100172022-05-25
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Recalling firm: Pfizer Inc.
Class IIAccupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 100172022-05-25
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Recalling firm: Pfizer Inc.
Class IIAccupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 100172022-05-25
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Recalling firm: Pfizer Inc.
Class IIquinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-92022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIquinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-12022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIAccuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .2022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.2022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIquinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-12022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.2022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.2022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIAccuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-232022-04-13
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Recalling firm: Pfizer Inc.
Class IIIQuinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-092017-04-12
Failed Impurities/Degradation Specifications; Impurity A
Recalling firm: Lupin Pharmaceuticals Inc.
Class IIIQuinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-152015-03-11
Subpotent Drug
Recalling firm: AVKARE Inc.
Class IIIQuinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-152015-03-11
Subpotent Drug
Recalling firm: AVKARE Inc.
Class IIQUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 681800558092014-01-22
Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP: 6/24/2014.
Recalling firm: Aidapak Services, LLC
Class IIQuinapril 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 68180-557-092014-01-22
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Recalling firm: Lupin Pharmaceuticals Inc.
Class IIQUINAPRIL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 597625020012014-01-22
Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC 23155011401, Pedigree: AD42566_4, EXP: 5/14/2014.
Recalling firm: Aidapak Services, LLC
Class IIQUINAPRIL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 317220270902014-01-22
Labeling: Label Mixup; QUINAPRIL Tablet, 40 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 16714002104, Pedigree: AD52778_73, EXP: 5/21/2014.
Recalling firm: Aidapak Services, LLC
Class IIQuinapril 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 68180-556-092014-01-22
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Recalling firm: Lupin Pharmaceuticals Inc.