RecallWatchUSA

Home / Recalls / Drugs

Bionpharma Inc. recalls Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Prince

Recalled July 31, 2019 · FDA recall D-1519-2019 · Bionpharma

Hazard
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. · FDA Class II
Units
3,020 bottles
Sold at
Nationwide in the USA

Description

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

Product
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Manufacturer(s)
Bionpharma Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov