FDA-Drug2019-07-31Class II
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.
Bionpharma Inc.
Hazard
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Sold states
Nationwide in the USA
Affected count
3,020 bottles
Manufactured in
600 Alexander Rd Ste 2-4b, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1519-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief