Recall: D-1296-2020

Class I - Dangerous

Class IClassification

2020-04-20Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

Product

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

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.