B. Braun Recalls Cefepime Injection Due to Visible Particulate Matter
B. Braun Medical Inc. is recalling Cefepime Hydrochloride and Dextrose injection units because visible particulate matter was found in reserve samples.
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 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling Cefepime Hydrochloride and Dextrose (Cefepime Hydrochloride) injection units. The recall is due to the presence of visible particulate matter found in reserve sample units.
The affected product is Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11. It is intended for IV use only, is a single-dose sterile product, and is available by prescription only. The specific lot number is H2L712, with an expiration date of 09/14.
The recall covers 22,248 units distributed nationwide, in Puerto Rico, and in Spain. The agency has classified this recall as Class I. Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)
- Brand
- CEFEPIME HYDROCHLORIDE AND DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Hazard
- Affected units
- 22,248
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# H2L712
- Exp 09/14
Distribution
Part of a larger recall action
This product is one of 12 recalled by B. Braun Medical Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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