Recalls / Class II
Class IID-0742-2021
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
- Affected lot / code info
- Lot #: 31329295B, exp date. 01/2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 2,199 vials
- Distribution pattern
- Product was distributed Nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-16
- Posted by FDA
- 2021-08-25
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0742-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.