The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0925-2016·Announced 2016-06-08

Baptist Health Pharmacy Recalls Dobutamine IV Bags Due to Sterility Concerns

Baptist Health Medical Towers Pharmacy is recalling Dobutamine IV bags in Arkansas due to a 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While specific injury reports are not detailed in the snippet, the 'Lack of Sterility Assurance' for an IV drug is a significant hazard that aligns with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Baptist Health Medical Towers Pharmacy and Infusion Services is recalling specific lots of Dobutamine 2000 mcg/mL in D5W IV bags. The recall involves 500 mL, 750 mL, 1000 mL, and 1750 mL bag sizes. The total quantity recalled is 48 bags (10, 23, 9, and 6 bags respectively for each size).

The recall was initiated due to a lack of sterility assurance. The affected products were distributed in Arkansas. The recall includes all product remaining within its expiry date.

Healthcare providers and consumers should stop using the affected Dobutamine IV bags immediately. Contact the recalling firm or the FDA for further instructions on disposal or replacement.

The recalled product

Product
Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Manufacturer
Baptist Health Medical Towers Pharmacy and Infusion Services
Category
Drug — IV Infusion
Hazard

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 →

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