Product: Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Reason for recall: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Recall initiated: 20191217
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated