Teva Alprostadil Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable product. Loss of sterility assurance in injectable pharmaceuticals poses a significant risk of serious infection and potential hospitalization, meeting the criteria for Severe classification even without reported illness data.
Plain-English summary
Teva Pharmaceuticals USA is recalling Alprostadil Injection USP, 500 mg/mL, 1 mL single-dose vials (NDC 0703-1501-01 and NDC 0703-1501-02) due to lack of assurance of sterility. The recalled lot is #31329295B with an expiration date of 01/2022, comprising 2,199 vials.
The product was distributed nationwide, including Puerto Rico. Alprostadil Injection is a prescription medication, and sterility assurance is critical for injectable products to prevent contamination and infection.
Patients currently using this product should consult their healthcare provider about whether they have a vial from the recalled lot and what steps to take. Healthcare providers and distributors should identify and quarantine any remaining product from lot #31329295B.
The recalled product
- 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, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 31329295B
- exp date. 01/2022
Distribution
Distributed nationwide across the United States.
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