Assurance Infusion Recalls Hydromorphone Injections Due to Sterility Concerns
Assurance Infusion is recalling specific lots of Hydromorphone 5mg/mL injections because they may lack 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. Under the rubric, FDA Class II recalls involving significant health risks like lack of sterility assurance are categorized as Severe.
Plain-English summary
Assurance Infusion is recalling Hydromorphone 5mg/mL injections packaged in 20 mL syringes. The recall is due to a lack of sterility assurance for the affected product.
The recall applies to Lot 12132019@4 with an expiration date of 12/22/2019. The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the recalled product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
- Hazard
- 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)
- Lot: 12132019@4 Exp. 12/22/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion 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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