Why it was recalled
Failed Dissolution Specifications: results were above specification.
Product description
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
Lot numbers, UPCs & expiration codes
Lot #: 194141, Exp. Date 03/31/2022
Where it was sold
Nationwide within the USA
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-0020-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2021
- FDA report date
- Oct 27, 2021
- Quantity
- 2,266 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0020-2022, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 88734
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 194141, Exp. Date 03/31/2022
- Postal code
- 43217-1188
- Report date
- Oct 27, 2021
- Product type
- Drugs
- Recall number
- D-0020-2022
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 2,266 cartons
- Termination date
- Jun 8, 2023
- Reason for recall
- Failed Dissolution Specifications: results were above specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Sep 17, 2021
- Center classification date
- Oct 20, 2021