Why it was recalled
Failed Impurities/Degradation Specifications; Impurity A
Product description
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Lot numbers, UPCs & expiration codes
Batch number G303703, exp 3/2016
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-0650-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 7, 2015
- FDA report date
- Apr 12, 2017
- Quantity
- 15,168 bottes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0650-2017, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 76924
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Batch number G303703, exp 3/2016
- Postal code
- 21202-6174
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0650-2017
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 15,168 bottes
- Termination date
- Apr 10, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications; Impurity A
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 7, 2015
- Initial firm notification
- Center classification date
- Apr 6, 2017