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.
What this means for you
Illness, injury, or structural failure has been reported. 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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