Recalls / Class III
Class IIID-0988-2022
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
- Affected lot / code info
- Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Why it was recalled
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 3109 cartons
- Distribution pattern
- Product was distributed nationwide in the US Market
Timeline
- Recall initiated
- 2022-05-18
- FDA classified
- 2022-06-07
- Posted by FDA
- 2022-06-15
- Terminated
- 2023-12-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0988-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.