Why it was recalled
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
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.
Lot numbers, UPCs & expiration codes
Lot EA6665, Exp Date 04/2022, Lot CN0640, Exp Date 04/2022
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-0756-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 1364 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0756-2022, 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 EA6665, Exp Date 04/2022, Lot CN0640, Exp Date 04/2022
- Postal code
- 10017-5703
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0756-2022
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1364 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
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 21, 2022
- Initial firm notification
- Press Release
- Center classification date
- Apr 6, 2022