B. Braun Recalls Cefoxitin and Dextrose Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling Cefoxitin and Dextrose injectable products due to visible particulate matter found in reserve sample units.
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 per the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container (NDC 0264-3123-11). The recall affects 22,584 units of the product, which is intended for intravenous use only.
The recall was initiated because visible particulate matter was found in reserve sample units. The affected product is identified by Lot# H3E507 with an expiration date of 11/14. The product was distributed nationwide, as well as in Puerto Rico and Spain.
Healthcare providers and patients should stop using the affected product and contact B. Braun Medical Inc. for further instructions or replacement. The product is a prescription-only sterile injectable.
The recalled product
- Product
- CEFOXITIN AND DEXTROSE (CEFOXITIN SODIUM)
- Brand
- CEFOXITIN AND DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 22,584
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# H3E507
- Exp 11/14
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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