Why it was recalled
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Product description
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
Lot numbers, UPCs & expiration codes
lot V112000, EXP Jun 2016
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-1059-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 4, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 22,529 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Greenstone Llc
Original FDA data
Every field from FDA enforcement report D-1059-2014, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66814
- Address
- 100 Route 206 North
- Code information
- lot V112000, EXP Jun 2016
- Postal code
- 07977
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1059-2014
- Classification
- Class III
- Recalling firm
- Greenstone Llc
- Product quantity
- 22,529 bottles
- Termination date
- Jun 24, 2015
- Reason for recall
- Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
- Distribution pattern
- US Nationwide (including PR)
- Recall initiation date
- Nov 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2014