Bionpharma Recalls Clobazam Oral Suspension Due to Microbial Contamination
Bionpharma Inc. is recalling Clobazam Oral Suspension due to out-of-specification microbial enumeration test results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination of a prescription drug, which fits the rubric criteria for Severe severity.
Plain-English summary
Bionpharma Inc. is recalling 3,020 bottles of Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottles. The product is distributed nationwide in the USA under NDC 69452-116-45. The specific lot affected is 18246, with an expiration date of 09/2020.
The recall was initiated because out-of-specification results were observed for Microbial Enumeration Tests USP <61>. This indicates microbial contamination of the non-sterile product. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Bionpharma Inc. for further instructions or a replacement.
The recalled product
- Product
- CLOBAZAM (CLOBAZAM)
- Brand
- CLOBAZAM
- Manufacturer
- Bionpharma Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 3,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 18246
- Exp 09/2020
Distribution
Distributed nationwide across the United States.
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