Why it was recalled
Failed Dissolution Specifications
Product description
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
Lot numbers, UPCs & expiration codes
Lot # B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC
Where it was sold
Product was distributed to a sold customer in FL.
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-0482-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2017
- FDA report date
- Mar 1, 2017
- Quantity
- 630 pills (21 bottles x 30 pills per HDPE bottle)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0482-2017, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 76457
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC
- Postal code
- 15701-3571
- Report date
- Mar 1, 2017
- Product type
- Drugs
- Recall number
- D-0482-2017
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 630 pills (21 bottles x 30 pills per HDPE bottle)
- Termination date
- May 5, 2017
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
- Distribution pattern
- Product was distributed to a sold customer in FL.
- Recall initiation date
- Feb 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 18, 2017