Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042...
FDA Recall #D-0864-2020 — Class I — December 17, 2019
Product Description
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.
Reason for Recall
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Recalling Firm
Hikma Pharmaceuticals USA Inc. — Cherry Hill, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
101,710 25 vials/shelf-pack
Distribution
Nationwide within the United States
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated