Injectable ceFAZolin Sodium Recalled for Lack of Sterility Assurance
Wells Pharma is recalling 825 syringes of injectable ceFAZolin sodium distributed in Philadelphia, Pennsylvania, due to lack of assurance that the product meets required sterility standards.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of an injectable medication with inherent risk to patients if product sterility is compromised. Although no illnesses or injuries have been reported, injectable medications are high-risk products where sterility is critical to safety. The score reflects that this is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Wells Pharma of Houston LLC is recalling ceFAZolin sodium in Sterile Water for injection, an injectable antibiotic solution (1g/10mL strength, NDC 73702-131-10). A total of 825 syringes are affected by this recall.
The recalled product was distributed in Philadelphia, Pennsylvania. It includes lot 11092313110#01 with an expiration date of 01/12/24. The recall was initiated because the manufacturer cannot assure that the product meets the required sterility standards for injectable medications.
Healthcare providers and patients who may have received doses from this lot should contact Wells Pharma or their healthcare provider. The recalled product should be removed from use immediately.
The recalled product
- Product
- ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
- Manufacturer
- Wells Pharma of Houston LLC
- Category
- Drug — Injectable Antibiotic
- Affected units
- 825
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 # 11092313110#01
- Exp 01/12/24
Distribution
Distributed in 1 state:
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