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
Reported: June 15, 2022 Initiated: May 18, 2022 #D-0988-2022
Product 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
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 3109 cartons
- Distribution
- Product was distributed nationwide in the US Market
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 3109 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 15, 2022. Severity: Low. Recall number: D-0988-2022.
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