B. Braun Recalls Cefepime Injection Due to Visible Organic Particulate Matter
B. Braun Medical Inc. is recalling 18,936 containers of Cefepime Hydrochloride and Dextrose Injection due to the presence of visible organic particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
B. Braun Medical Inc. is recalling 18,936 containers of Cefepime Hydrochloride and Dextrose Injection USP. The product is a 1 g Cefepime for Injection USP and Dextrose Injection USP in a 50 mL duplex container intended for intravenous use only. The specific lot affected is H3A744, with an expiration date of 01/15, and the product was distributed nationwide.
The recall was initiated because visible organic particulate matter was found in a reserve sample unit of the affected lot. The FDA has classified this recall as Class I, indicating a reasonable probability that use of or exposure to the violative product may cause serious adverse health consequences or death.
Healthcare providers and facilities that have received this product should stop using it and contact B. Braun Medical Inc. for further instructions. Patients who have received this specific lot should consult their healthcare provider if they have any concerns or experience adverse effects.
The recalled product
- Product
- CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
- Brand
- CEFEPIME HYDROCHLORIDE AND DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 18,936
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 H3A744
- Exp 01/15
Distribution
Distributed nationwide across the United States.
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