Why it was recalled
Failed Dissolution Specification; 8 hr stability timepoint
Product description
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
Lot numbers, UPCs & expiration codes
Lot V120131
Where it was sold
US nationwide (including PR)
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-1058-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 4, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 14,357 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1058-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66816
- Address
- 235 East 42nd Street
- Code information
- Lot V120131
- Postal code
- 10017-5703
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1058-2014
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 14,357 bottles
- Termination date
- Jun 24, 2015
- Reason for recall
- Failed Dissolution Specification; 8 hr stability timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
- Distribution pattern
- US nationwide (including PR)
- Recall initiation date
- Nov 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2014