The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0974-2015·Announced 2015-05-13

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

Distributed in 2 states:

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