Reported Jan 22, 2020 · Terminated
Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
Assurance Infusion
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Assurance Infusion · 2626 S Loop W Ste 555 · Houston, TX · 77054-2652
Is this the product you have?
- Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800
- Lot codes and dates
- Lots
09262019@13 Exp. 03/24/202010072019@03/04/202012062019@2 Exp. 06/03/202012172019@12 Exp. 01/31/202008142019@20 Exp. 02/10/2020
- Lots
- Amount recalled
- 60 vials
This recall covers 118 products
The agency filed one notice per product. You are reading one of them; the other 117 are below.
105 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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