Clobazam Oral Suspension recalled over sterility concerns
- Recall date
- July 16, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bionpharma Inc. recalls Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princ…
- Recall number
- D-1519-2019
- FDA classification
- Class II
- Brand / firm
- Bionpharma Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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