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, 10 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 68180-557-09
Lot numbers, UPCs & expiration codes
Lot 3110358 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-409-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 22, 896 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-409-2014, 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
- Lot 3110358 Exp. 12/13
- Postal code
- 21202-6174
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-409-2014
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 22, 896 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, 10 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 68180-557-09
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 17, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 10, 2014