B. Braun Recalls Ceftazidime and Dextrose Injection Due to Stability Failures
B. Braun Medical Inc. is recalling one lot of Ceftazidime for Injection USP and Dextrose for Injection USP because the product failed stability specifications for high molecular weight polymers.
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 FDA classified this as a Class I recall, which is the highest risk category indicating a reasonable probability that the product will cause serious adverse health consequences or death. The rubric states that FDA Class I recalls must be scored at least 4.
Plain-English summary
B. Braun Medical Inc., located in Bethlehem, PA, has initiated a voluntary recall of one lot of Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container. The product is available by prescription only (RX only) and carries National Drug Code (NDC) 0264-3145-11.
The recall was triggered because testing revealed out-of-specification results for High Molecular Weight Polymers in the affected lots. This failure indicates that the product does not meet its established stability specifications.
The recalled product includes 22,488 duplex containers distributed nationwide within the United States. The specific lot subject to this recall is H8J812, with an expiration date of July 31, 2020.
Healthcare providers and patients should check their inventory for the identified lot number and expiration date. Any affected units should be returned or handled according to standard pharmaceutical recall procedures.
The recalled product
- Product
- Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injection / Antibiotic
- Affected units
- 22,488
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 #: H8J812
- Exp. Date 31 JUL 2020
Distribution
Distributed nationwide across the United States.
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