FDA Recall Quinapril Hydrochloride And Hydrochlorothiazide
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Quinapril Hydrochloride And Hydrochlorothiazide with NDC 59762-0222 was initiated on 03-21-2022 as a Class II recall due to cgmp deviations: n-nitroso-quinapril and n-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. The latest recall number for this product is D-0760-2022 and the recall is currently ongoing .
Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
---|---|---|---|---|---|---|
D-0760-2022 | 03-21-2022 | 04-13-2022 | Class II | 1104 bottles | quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1 | Ongoing |
D-0758-2022 | 03-21-2022 | 04-13-2022 | Class II | 2442 bottles | quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9 | Ongoing |
D-0759-2022 | 03-21-2022 | 04-13-2022 | Class II | 21108 bottles | quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1 | Ongoing |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.