Class II
Terminated
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.
This recall has been terminated (originally issued January 22, 2020).
- Company
- Hikma Pharmaceuticals Usa Inc.
- Recall Initiated
- December 17, 2019
- Posted
- January 22, 2020
- Recall Number
- D-0658-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25,817 shelf packs/25 vials per pack
- Firm Location
- Cherry Hill, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Distribution
Nationwide within the United States
Lot / Code Info
038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
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