FDA recall D-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.

Reason for recall

CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-03-27

Report date

2023-04-12

Termination date

2023-10-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0505-2023