Why it was recalled
Subpotent Drug
Product description
Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
Lot numbers, UPCs & expiration codes
Lot number: I1404952, Exp. 02/2016
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-0401-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 27, 2015
- FDA report date
- Mar 11, 2015
- Quantity
- 214 unit dose packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-0401-2015, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 70635
- Address
- 615 N 1st St
- Code information
- Lot number: I1404952, Exp. 02/2016
- Postal code
- 38478-2403
- Report date
- Mar 11, 2015
- Product type
- Drugs
- Recall number
- D-0401-2015
- Classification
- Class III
- Recalling firm
- AVKARE Inc.
- Product quantity
- 214 unit dose packs
- Termination date
- Sep 22, 2015
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 27, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 4, 2015