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.
Recall Number: D-1519-2019
Firm: Bionpharma Inc.
Classification: Class II
Status: Terminated
Report Date: 20190731
Initiation Date: 20190716
Termination Date: 20200305
Reason for Recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Product Description
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.