D-0759-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2022
- Initiation Date
- March 21, 2022
- Termination Date
- August 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21108 bottles
Product Description
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
Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Distribution Pattern
Nationwide
Code Information
Lots DN6931, ED3904 & ED3905; Exp. 03/2023