SCA Pharmaceuticals Recalls Cefazolin Sodium Bags Due to Leaking
SCA Pharmaceuticals is recalling 70 bags of cefazolin sodium due to leaks at the seam, which compromises the product's sterility.
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 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 recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 70 bags of cefazolin sodium added to 100 mL 0.9% Sodium Chloride injectable. The product is a 3g, single-dose container bag that is preservative-free and requires a prescription. The specific lot number is 20170508@15, with a use-by date of 06/22/17.
The recall was initiated because the product bags were found to be leaking at the seam. This defect creates a lack of assurance regarding the sterility of the injectable solution. The affected product was distributed nationwide in the USA.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and use-by date listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Affected units
- 70
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 # 20170508@15
- Use By: 06/22/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals 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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