Reported Feb 3, 2021 · Terminated
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL…
Fresenius Kabi USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00) |
| 2 | 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01) |
| 3 | For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. |
- Lot codes and dates
Lot # 6121083Exp 2/2021
- Amount recalled
- 945,425 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Presence of Particulate Matter - found in reserve sample vials at the firm.
Using this product could cause serious injury, illness or death — stop using it now.
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