Recalls / Class II
Class IID-0161-2016
Product
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
- Brand name
- Xanax
- Generic name
- Alprazolam
- Active ingredient
- Alprazolam
- Route
- Oral
- NDCs
- 0009-0090, 0009-0029, 0009-0055, 0009-0094
- FDA application
- NDA018276
- Affected lot / code info
- Lot # C111054; Exp. 02/16
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- PHARMACIA & UPJOHN COMPANY LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 21,120 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-09-24
- FDA classified
- 2015-10-29
- Posted by FDA
- 2015-11-04
- Terminated
- 2017-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0161-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.