Accuretic (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.
Reported: April 13, 2022 Initiated: March 21, 2022 #D-0756-2022
Product Description
Accuretic (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.
Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 1364 bottles
- Distribution
- Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Accuretic (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.. Recalled by Pfizer Inc.. Units affected: 1364 bottles.
Why was this product recalled? ▼
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0756-2022.
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