Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization
Hospira Inc. is recalling specific lots of Ketorolac Tromethamine Injection due to the presence of crystals 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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a physical defect (crystallization) rather than a high-risk pathogen or structural failure.
Plain-English summary
Hospira Inc. is recalling specific lots of KETOROLAC Tromethamine Injection, USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials. The recall affects products labeled under both the Hospira and NOVAPLUS brands. The affected lots were distributed nationwide, as well as to Puerto Rico, Guam, Canada, and Singapore.
The recall was initiated because crystals were identified in the product. These crystals were determined to be the calcium salt of Ketorolac. The source text does not report any illnesses or injuries associated with the use of these products.
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
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)
- 31075DK
- 31076DK
- EXP01JUL2015
- 32345DK
- 32368DK
- EXP 01AUG2015
- 33152DK
- EXP 01SEP2015
- 34538DK
- EXP 01OCT2015
- 37227DK
- EXP 01JAN2016
- 41525DK
- 42255DK
- EXP 01MAY2016
- 46042DK
- 46045DK
- 46048DK
- 46304DK
- 46305DK
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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