D-0658-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- June 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,817 shelf packs/25 vials per pack
Product Description
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)
Distribution Pattern
Nationwide within the United States
Code Information
038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020