B. Braun Recalls Ceftriaxone Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.
Plain-English summary
B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11. The recall is being conducted because visible particulate matter was found in reserve sample units of the product.
The affected product is identified by Lot# H3B702 with an expiration date of 02/15. A total of 32,376 units were distributed nationwide, as well as in Puerto Rico and Spain. The product is intended for IV use only and is a single-dose, sterile, prescription-only medication.
Healthcare providers and patients should stop using the affected product and contact B. Braun Medical Inc. or their local FDA office for further instructions on how to return or dispose of the recalled units.
The recalled product
- Product
- Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable Medication
- Affected units
- 32,376
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# H3B702
- Exp 02/15
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.
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