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
Reported: November 21, 2018 Initiated: September 27, 2018 #D-0244-2019
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 1,362 vials
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 1,362 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 21, 2018. Severity: Moderate. Recall number: D-0244-2019.
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