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.
Reported: January 22, 2020 Initiated: December 17, 2019 #D-0658-2020
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)
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 25,817 shelf packs/25 vials per pack
- Distribution
- Nationwide within the United States
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 25,817 shelf packs/25 vials per pack.
Why was this product recalled? ▼
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2020. Severity: Moderate. Recall number: D-0658-2020.
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