Why it was recalled
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Product description
Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09
Lot numbers, UPCs & expiration codes
Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
Where it was sold
Nationwide and Puerto Rico
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-408-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 30,264 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-408-2014, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 66345
- Address
- 111 S Calvert St Fl 21st
- Code information
- Lots 3104879, 3104880, Exp. 10/13, 3110218, 3110219, 3110220 Exp. 12/13
- Postal code
- 21202-6174
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-408-2014
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 30,264 bottles
- Termination date
- May 11, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 17, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 10, 2014