Recalls / Class II
Class IID-0244-2019
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 0703-1501-02
- Affected lot / code info
- Lot # 31323147B, exp. date 01/2019
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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 1,362 vials
- Distribution pattern
- Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Timeline
- Recall initiated
- 2018-09-27
- FDA classified
- 2018-11-14
- Posted by FDA
- 2018-11-21
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0244-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.