Avella Recalls CeFAZolin Bags Due to Potential Leakage and Sterility Concerns
Avella of Deer Valley, Inc. is recalling 2,500 bags of ceFAZolin 2 gm in NS 100mL due to potential bag leakage that compromises sterility.
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, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks, such as sterility failures in medical products.
Plain-English summary
Avella of Deer Valley, Inc. is recalling 2,500 single-dose bags of ceFAZolin 2 gm in NS 100mL. The recall is being conducted because of a lack of assurance of sterility, specifically due to potential leakage of the bags.
The affected product is ceFAZolin Sodium (USP) 2gm in 0.9% Sodium Chloride (USP) 100mL, with a total volume of 110 mL. The specific lot numbers involved are 4/27/18 2002 60410P and 4/27/18 2030 60410P, with a beyond-use date of 6/26/2018. The product was distributed nationwide in the USA.
Healthcare providers and consumers should stop using the affected product and contact Avella of Deer Valley, Inc. for further instructions or to arrange for a return.
The recalled product
- Product
- ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 2,500
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 (3)
- Lot # 4/27/18 2002 60410P
- 4/27/18 2030 60410P
- BUD 6/26/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 recalled by Avella of Deer Valley, Inc. Store 38 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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