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Class III · Lower riskRecall completed

Alprostadil Injection USP 500 mcg/mL

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Where it was soldProduct was distributed nationwide in the US Market
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forTeva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial
NDC0703-1501-02
Show the full FDA record
Full product labelAlprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
Recalling firmTeva Pharmaceuticals USA Inc
DistributionProduct was distributed nationwide in the US Market
Quantity3109 cartons
Recall initiated2022-05-18
Report date2022-06-15
Recall completed2023-12-08
Recall numberD-0988-2022
ClassificationClass III
FDA statusTerminated
Origin on fileParsippany NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.