Why it was recalled
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Product description
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Lot numbers, UPCs & expiration codes
Lot EJ9591
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-1509-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 25, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 1,332 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-1509-2014, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 68900
- Address
- 2555 W Midway Blvd
- Code information
- Lot EJ9591
- Postal code
- 80020-1632
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1509-2014
- Classification
- Class II
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 1,332 bottles
- Termination date
- Feb 5, 2015
- Reason for recall
- Presence of Foreign Substance; tablets may contain stainless steel metal particulates
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 25, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2014