RemedyRepack Recalls Ketorolac Tromethamine Injection Due to Crystallization
RemedyRepack Inc. is voluntarily recalling 25 vials of Ketorolac Tromethamine Injection 30 mg/mL due to crystallization. The product was distributed in Pennsylvania and Oklahoma.
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 is a voluntary, firm-initiated action for crystallization, which fits the criteria for a moderate severity recall involving a potential defect without reported serious injury.
Plain-English summary
RemedyRepack Inc. has initiated a voluntary recall of 25 units of Ketorolac Tromethamine Injection 30 mg/mL, 1 mL glass vials. The product is repackaged individually inside an amber glass bottle and was manufactured by Hospira, Inc. The recall was initiated on April 23, 2015, and was terminated on August 18, 2015.
The reason for the recall is crystallization. The affected product includes lots B0069266-013015, B0069264-013015, and B0066712-011415, all with an expiration date of September 1, 2016. The product was distributed in Pennsylvania and Oklahoma.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 25
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 (4)
- Lot # B0069266-013015
- Lot # B0069264-013015
- Lot # B0066712-011415
- EXP DATE 9/01/2016
Distribution
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