Recall: D-0184-2021
Class II - Potentially Harmful
Class IIClassification
2020-12-17Initiated
TerminatedStatus
Fresenius Kabi USA, LLCFirm
Product
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Reason
Presence of Particulate Matter - found in reserve sample vials at the firm.
Distribution
USA Nationwide and Puerto Rico
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.