B. Braun Recalls 5% Dextrose Injection Due to Fungal Contamination
B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP due to non-sterility caused by fungal contamination from leaking containers.
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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP, 100mL in a 150 mL PAB container. The product is identified by NDC 00264-1510-32, Lot # J5J706, and an expiration date of 10/31/2016.
The recall was initiated due to non-sterility, specifically fungal contamination resulting from leaking containers. The affected units were distributed nationwide.
Healthcare providers and patients should stop using the recalled product immediately. Consumers should contact their healthcare provider for further instructions on how to proceed.
The recalled product
- Product
- 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Affected units
- 57,408
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 #: J5J706
- Exp. 10/31/2016
Distribution
Distributed nationwide across the United States.
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