Recalls / Class II
Class IID-1509-2014
Product
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
- Brand name
- Alprazolam
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 0781-1061, 0781-1077, 0781-1079, 0781-1089
- FDA application
- ANDA074112
- Affected lot / code info
- Lot EJ9591
Why it was recalled
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Recalling firm
- Firm
- Sandoz Incorporated
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 1,332 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-25
- FDA classified
- 2014-07-31
- Posted by FDA
- 2014-08-06
- Terminated
- 2015-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1509-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.