Remicade IV Bags Recalled for Lack of Sterility Assurance
Baptist Health Medical Towers Pharmacy recalls Remicade IV bags in Arkansas 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (infection) from lack of sterility assurance without reported illnesses, fitting the High severity criteria.
Plain-English summary
Baptist Health Medical Towers Pharmacy and Infusion Services is recalling Remicade 600 mg in 250 mL 0.9% NS bags for IV use. The recall was initiated due to a lack of sterility assurance for the product.
The affected product was distributed in Arkansas. The recall covers 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
- Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
- Category
- Drug — Biologic
- Affected units
- 1
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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