Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-p…
- Recall date
- December 17, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0864-2020
- FDA classification
- Class I
- Brand / firm
- Hikma Pharmaceuticals USA Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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.
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