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
Reported: September 6, 2017 Initiated: August 15, 2017 #D-1124-2017
Product Description
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
Reason for Recall
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Details
- Recalling Firm
- Amphastar Pharmaceuticals, Inc.
- Units Affected
- 637,810 vials
- Distribution
- Distributed throughout the United States
- Location
- Rancho Cucamonga, CA
Frequently Asked Questions
What product 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. Recalled by Amphastar Pharmaceuticals, Inc.. Units affected: 637,810 vials.
Why was this product recalled? ▼
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 6, 2017. Severity: Moderate. Recall number: D-1124-2017.
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