AuroMedics Pharma LLC 2022-11-02 Health serious FDA
Health · FDA · Recall #FDA-D-0020-2023
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe,… Recall
Issued November 2, 2022 · AuroMedics Pharma LLC
In November 2022, AuroMedics Pharma LLC recalled the Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Subpotent Drug: Out of specification for assay
What you should do
- 1 Stop using Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact AuroMedics Pharma LLC 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
- AuroMedics Pharma LLC
- Category
- Health
- Recall date
- November 2, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0020-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- AuroMedics Pharma LLC has 3 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.