Teva Pharmaceuticals USA Inc 2022-06-15 Health moderate FDA
Health · FDA · Recall #FDA-D-0988-2022
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only,… Recall
Issued June 15, 2022 · Teva Pharmaceuticals USA Inc
In June 2022, Teva Pharmaceuticals USA Inc recalled the Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only,…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
What you should do
- 1 Stop using Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Teva Pharmaceuticals USA Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Teva Pharmaceuticals USA Inc
- Category
- Health
- Recall date
- June 15, 2022
- Units affected
- Not reported
- Sold at
- Product was distributed nationwide in the US Market
- Recall number
- FDA-D-0988-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Teva Pharmaceuticals USA Inc has 8 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.