FDAFDA · Food and drugs·Recall number D-0864-2020
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Published January 22, 2020 · Recall initiated: December 17, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.