Leiter's Compounding Recalls Cefuroxime Sodium Injection Due to Sterility Concerns
Leiter's Compounding is recalling Cefuroxime Sodium Injection because products were made with recalled filters, raising sterility concerns.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Leiter's Compounding is recalling Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride Injection, 1 mL Total Volume in a 2 mL Vial (Preservative Free). The recall involves 76,315 total units distributed nationwide. The affected products have expiration dates ranging from 09/24/2016 to 02/06/2017.
The recall is being conducted due to a lack of assurance of sterility. The source text indicates that all compounded products within the expiry period were produced using recalled filters.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
- Manufacturer
- Leiter's Compounding
- Category
- Drug — Injectable
- Hazard
- Affected units
- 76,315
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)
- All unexpired lots
- Expirations dates of 09/24/2016 to 02/06/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Leiter's Compounding 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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