The Recall Desk
SevereFDA (Drugs)·D-0944-2016·Announced 2016-06-08

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.

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. 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
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.

See all 38 products in this recall →