Assurance Infusion Recalls Alprostadil Injection Due to Sterility Concerns
Assurance Infusion is recalling Alprostadil 40 mcg/mL injection vials nationwide 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks associated with lack of sterility assurance.
Plain-English summary
Assurance Infusion is recalling 60 vials of Alprostadil 40 mcg/mL (2 mL vial) Injection Solution. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product was distributed nationwide within the United States. Specific lots involved in the recall include 09262019@13, 10072019@03/04/2020, 12062019@2, 12172019@12, and 08142019@20.
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
- Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 60
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 (5)
- Lots: 09262019@13 Exp. 03/24/2020
- 10072019@03/04/2020
- 12062019@2 Exp. 06/03/2020
- 12172019@12 Exp. 01/31/2020
- 08142019@20 Exp. 02/10/2020
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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