Teva Pharmaceuticals recalls Alprostadil Injection USP 500 mcg/mL vials due to impurities found in stability testing. This medication may cause serious injury if used improperly.
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Teva Pharmaceuticals is recalling Alprostadil Injection USP 500 mcg/mL vials because impurities were detected during routine stability testing. This could lead to serious injury if the medication is used incorrectly.
The medication contains impurities that were not within acceptable levels during stability testing. These impurities could cause serious injury if the product is used as intended.
People with prescriptions for this medication are affected. Those using the product for erectile dysfunction or other medical conditions are at risk.
Check for vials labeled 'Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton' with NDC 0703-1501-01. The product was distributed by Teva Pharmaceuticals USA, Inc. in specific lots.
Look for the NDC code 0703-1501-01 on the vial and lot numbers 100022404 or 100023333.
The recall record states that impurities were found during stability testing, but does not specify if the product is safe to use.
Check for vials labeled 'Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton' with NDC 0703-1501-01 and lot numbers 100022404 or 100023333.
The recall record does not specify any remedy, so the official notice does not provide instructions on what to do.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0988-2022 — Teva Teva Hello, I own a Teva that is covered by recall D-0988-2022 from Teva. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
