Why it was recalled
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Product description
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
Lot numbers, UPCs & expiration codes
Lot DP3414; Exp 02/2023
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0760-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 1104 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0760-2022, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89864
- Address
- 235 East 42nd Street
- Code information
- Lot DP3414; Exp 02/2023
- Postal code
- 10017-5703
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0760-2022
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1104 bottles
- Termination date
- Aug 28, 2024
- Reason for recall
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 21, 2022
- Initial firm notification
- Press Release
- Center classification date
- Apr 6, 2022