Amphastar Recalls Ketorolac Injection Due to Crystallization
Amphastar Pharmaceuticals is recalling Ketorolac Tromethamine Injection because crystallization was observed in retained samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Amphastar Pharmaceuticals, Inc. is recalling Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials. The recall involves 637,810 vials distributed throughout the United States.
The recall was initiated because crystallization, specifically particulate matter identified as Ketorolac Calcium Salt, was observed from several lots of retained samples. The affected lots include specific expiration dates ranging from December 2017 to March 2019.
Healthcare providers and patients should discontinue use of the affected vials and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Category
- Drug — Injection
- Affected units
- 637,810
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # XI002A6
- XI003A6
- Exp 12/17
- XI004G6
- XI005G6
- Exp 6/18
- XI007H6
- Exp 7/18
- XI00816
- XI00916
- XI01016
- XI01116
- Exp 8/18
- XI012J6
- XI013J6
- Exp 9/18
- XI015K6
- Exp 10/18
- XI016L6
- Exp 11/18
Distribution
Distribution scope not specified by the agency.
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