Recall: D-0658-2020

Class II - Potentially Harmful

Class IIClassification

2019-12-17Initiated

TerminatedStatus

Hikma Pharmaceuticals USA Inc.Firm

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

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.