Key Takeaway
Alprostadil 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- by Teva Pharmaceuticals USA, Inc. was recalled on May 18, 2022. The hazard: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Alprostadil 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-
Description
Alprostadil 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
Hazard / Reason
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class III: Product that is not likely to cause adverse health consequences.
Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.
Products Affected
Alprostadil 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-
DrugsCompany Information
Teva Pharmaceuticals USA, Inc.
Sellersville, PA, United States
View all 69 recalls by Teva Pharmaceuticals USA, Inc. →Distribution
Product was distributed nationwide in the US Market
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.