B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
B. Braun Medical Inc. is recalling Cefazolin Sodium (Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container) due to the presence of visible particulate matter. The recall affects 42,576 units of the product, which is distributed nationwide, in Puerto Rico, and in Spain.
The specific lots affected are H2S723 (Expiration 07/14) and H3H711 (Expiration 01/15). The product is identified by NDC 0264-3105-11 and Catalog Number 3105-11. The issue was identified when visible particulate matter was found in reserve sample units.
Healthcare providers and patients should stop using the affected lots and contact B. Braun Medical Inc. for further instructions or replacement products. This recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
- Brand
- CEFAZOLIN SODIUM
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable Antibiotic
- Affected units
- 42,576
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 (4)
- Lot# H2S723
- Exp 07/14
- H3H711
- Exp 01/15
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.
See all 12 products in this recall →Related recalls
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