Why it was recalled
Failed Dissolution Specifications: low out of specification results for dissolution.
Product description
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
Lot numbers, UPCs & expiration codes
Lot #: DX7983, exp. date 02/28/2023
Where it was sold
Product was distributed nationwide in 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-0854-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2022
- FDA report date
- May 18, 2022
- Quantity
- 110 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0854-2022, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90091
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: DX7983, exp. date 02/28/2023
- Postal code
- 15317-5853
- Report date
- May 18, 2022
- Product type
- Drugs
- Recall number
- D-0854-2022
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 110 bottles
- Termination date
- Jul 13, 2023
- Reason for recall
- Failed Dissolution Specifications: low out of specification results for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
- Distribution pattern
- Product was distributed nationwide in the USA
- Recall initiation date
- Apr 28, 2022
- Initial firm notification
- Letter
- Center classification date
- May 6, 2022