FDAClass IIAugust 25, 2021

Alprostadil Injection USP recall: Sterility Concern

Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA…

Why was Alprostadil Injection USP recalled?

Lack of Assurance of Sterility

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 #: 31329295B, exp date. 01/2022

Product
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA…
Recalling firm
Teva Pharmaceuticals USA
Quantity
2,199 vials
Distribution
Product was distributed Nationwide, including Puerto Rico.
Recall date
August 25, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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