Alprostadil Injection USP 500 micrograms/mL recall: Impurity Out of Spec
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC…
Why was Alprostadil Injection USP 500 micrograms/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 # 31323147B, exp. date 01/2019
- Product
- Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 1,362 vials
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico.
- Recall date
- November 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)