Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization
Hospira Inc. is recalling Ketorolac Tromethamine Injections because crystallization was identified as the calcium salt of Ketorolac.
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, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Hospira Inc. is recalling specific lots of Ketorolac Tromethamine Injections, USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials. The recall was initiated because crystallization was identified in the product, which was determined to be the calcium salt of Ketorolac.
The affected product is labeled under NDC 0409-3795-01 and also under the NOVAPLUS label NDC 0409-3795-49. The recall covers 12,460,975 vials under the Hospira label and 3,016,500 vials under the NOVAPLUS label. The product was distributed nationwide, as well as to Puerto Rico, Guam, Canada, and Singapore.
Healthcare providers and patients should stop using the affected lots and contact Hospira Inc. for further instructions. The specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Hazard
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)
- 31077DK
- 31078DK
- 31338DK
- 31339DK
- 31340DK
- EXP 01JUL2015
- 32068DK
- 32069DK
- EXP 01AUG2915
- 33270DK
- EXP 01SEP2015
- 34084DK
- 34085DK
- 34161DK
- 34162DK
- 34298DK
- 34299DK
- 34300DK
- EXP 01OCT2015
- 35011DK
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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