Banner Health Recalls Vancomycin Bags Due to Sterility Concerns
Banner Pharmacy Services is recalling 2,443 bags of Vancomycin in sodium chloride due to a lack of assurance of 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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Banner Pharmacy Services, LLC is recalling 2,443 bags of VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag. The product is identified by Lot # 082817S2 and has an expiration date of 10/14/2017. The recall is being conducted because of a lack of assurance of sterility.
The affected product was distributed nationwide within the United States. The recall is classified as FDA Class II by the U.S. Food and Drug Administration.
Consumers and healthcare providers should stop using the affected product and contact Banner Pharmacy Services for further instructions or a replacement.
The recalled product
- Product
- VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001
- Manufacturer
- Banner Pharmacy Services, LLC
- Category
- Drug — Injectable
- Affected units
- 2,443
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 #: 082817S2
- Exp 10/14/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Banner Pharmacy Services, LLC 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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