Recalls / Class II
Class IID-0505-2023
Product
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
- Affected lot / code info
- Lot # a) D2022P, Exp. Date:4/30/2023; F1022Y, E2022, I2822U, Exp. Date:6/30/2023; L2122W, Exp. Date: 8/31/2024; b) Lot #L0522A, Exp. Date:8/31/2024; B0823J, Exp. Date:11/31/2024; c) Lot# L1522P, Exp. Date: 10/31/2024.
Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 320 x 30-count; 46 x 60-count; 10 x 90-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-27
- FDA classified
- 2023-04-05
- Posted by FDA
- 2023-04-12
- Terminated
- 2023-10-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0505-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.