Amphastar Pharmaceuticals, Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals,…
- Recall date
- August 15, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1124-2017
- FDA classification
- Class II
- Brand / firm
- Amphastar Pharmaceuticals, Inc.
- Sold / distributed
- Distributed throughout the United States
Why it was recalled
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Get recall alerts
Free email alert whenever Amphastar Pharmaceuticals, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Amphastar Pharmaceuticals, Inc.