Alprostadil Injection USP 500 mcg/mL recall: Impurity Out of Spec
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
Why was Alprostadil Injection USP 500 mcg/mL recalled?
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
- Product
- 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
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Quantity
- 3109 cartons
- Distribution
- Product was distributed nationwide in the US Market
- Recall date
- June 15, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)