FDA-Drug2020-01-22Class I
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.
Hikma Pharmaceuticals USA Inc.
Hazard
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Sold states
Nationwide within the United States
Affected count
101,710 25 vials/shelf-pack
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0864-2020Don't want to check this manually?
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