Pacific Compounding Recalls Cefuroxime Injection Due to Particulate Matter
Pacific Compounding Pharmacy is recalling one lot of Cefuroxime injection because FDA analysis found rubber stopper fragments in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is identified as rubber stopper fragments (particulate matter) rather than a high-risk pathogen or structural defect leading to severe injury.
Plain-English summary
Pacific Compounding Pharmacy & Consultations Inc is recalling one lot of Cefuroxime 10mg/mL injection (41.4 mL) due to the presence of particulate matter. The recall is limited to Lot # 07232018@15 with a beyond-use date of 9/6/18 (frozen).
A physician reported the presence of particulate matter after using the product. Subsequent FDA analysis identified the particulate as coring of the rubber stopper. The product was distributed in California.
Consumers and healthcare providers should stop using the affected lot and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
- Manufacturer
- Pacific Compounding Pharmacy & Consultations Inc
- Category
- Drug — Injectable
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 (1)
- Lot # 07232018@15 BUD 9/6/18 (frozen)
Distribution
Distributed in 1 state:
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