Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns
Baptist Health Medical Towers Pharmacy is recalling 84 bags of Vancomycin 1250 mg in 250 mL 0.9% NS due to lack of sterility assurance.
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 or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an IV medication poses a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
Baptist Health Medical Towers Pharmacy and Infusion Services in Little Rock, Arkansas, is recalling 84 bags of Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY. The recall was initiated due to a lack of sterility assurance for the product.
The affected product was distributed in Arkansas. The recall includes all product remaining within its expiry date.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 84
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 (1)
- All product remaining within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 38 recalled by Baptist Health Medical Towers Pharmacy and Infusion Services 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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