FDA recall D-0461-2023

Product

Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Reason for recall

CGMP Deviations: Potential risk of Cross Contamination

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2023-03-02

Report date

2023-03-22

Termination date

2024-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0461-2023