Baptist Health Recalls Hydromorphone IV Bags Due to Sterility Concerns
Baptist Health Medical Towers Pharmacy is recalling three bags of Hydromorphone 2 mg/mL IV solution 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 classification is FDA Class II. Per the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterility issues in IV products which carry significant risk of infection.
Plain-English summary
Baptist Health Medical Towers Pharmacy and Infusion Services is recalling three bags of Hydromorphone 2 mg/mL (500 mg in 250 mL NS) solution intended for intravenous use. The product was distributed in Arkansas. The recall was initiated because of a lack of sterility assurance.
The affected product is identified by the description: Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY. The recall covers all product remaining within its expiry date. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 3
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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