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.

FDA recall notice · announced July 31, 2019 · Bionpharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 18246, Exp 09/2020
Quantity: 3,020 bottles
Status: Terminated
Products in this recall event:
- 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. (D-1519-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.