FDAFDA · Food and drugs·Recall number D-0658-2020
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.
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
- 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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