Why it was recalled
CGMP Deviations; rejected product was used to manufacture final bulk lot
Product description
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
Lot numbers, UPCs & expiration codes
Lot: T71137 Exp. Feb. 2022
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-0010-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 20, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 7777 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0010-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81028
- Address
- 235 E 42nd St
- Code information
- Lot: T71137 Exp. Feb. 2022
- Postal code
- 10017-5703
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0010-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 7777 bottles
- Termination date
- May 8, 2020
- Reason for recall
- CGMP Deviations; rejected product was used to manufacture final bulk lot
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2018