Agency classClass IIOur severity:Severe FDA (Drugs)·D-1001-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls CeFAZolin Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling 108 bags of CeFAZolin 3 g in 0.9% Sodium Chloride because the product was made with recalled saline bags that may leak, compromising 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no injuries are reported, the potential for sterility failure in an IV drug is a significant risk warranting a Severe classification under the Class II criteria.

Plain-English summary

SCA Pharmaceuticals is recalling 108 bags of CeFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag. The product is prescription-only and was distributed nationwide in the USA. The specific lot number is 20170707@26, with a beyond-use date of 8/21/2017.

The recall was initiated due to a lack of assurance of sterility. The product was manufactured using 0.9% sodium chloride bags that were previously recalled because they have the potential to leak. This defect raises concerns about the sterility of the final drug product.

Healthcare providers and patients should stop using the affected product. The source text does not specify additional consumer actions or report any illnesses or injuries associated with this recall.

The recalled product

Product: ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Antibiotic
Hazard: sterility
leakage
Affected units: 108

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: 20170707@26
BUD: 8/21/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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.

See all 6 products in this recall →

Same manufacturer · SCA Pharmaceuticals

See all →

High
SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
Moderate
FDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
Moderate
Fentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
Moderate
Norepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations
FDA (Drugs) · 2022-05-11
Moderate
Drug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11

Same hazard · sterility