Recalls / Class II
Class IID-0642-2022
Product
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
- Affected lot / code info
- Lot #s: a) G2919M, I0619O, F1419J; b) H3019Q; c) F1219N, F1919D, H0219D, I0519R, J0319G, Exp. 03/31/2022.
Why it was recalled
CGMP deviations
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 276 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-02-22
- FDA classified
- 2022-03-01
- Posted by FDA
- 2022-03-09
- Terminated
- 2023-05-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0642-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.