The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0484-2015·Announced 2015-04-15

RemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization

RemedyRepack Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The affected vials were 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 aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls without reported serious injury.

Plain-English summary

RemedyRepack Inc. has initiated a voluntary recall of Ketorolac Tromethamine 30 mg/mL Injection, 1 mL glass vials. The recall is due to crystallization in the product. The affected product was repackaged by RemedyRepack Inc. in Indiana, PA, and manufactured by Hospira, Inc. in Lake Forest, IL.

The recall covers 25 vials packaged in amber glass bottles. Specific affected lots include B00484449-100914, B0062349-121914, and B006655-011415, all with an expiration date of 04/01/2016. The NDC number for the product is 61786-0055-01.

Distribution of the affected product was limited to Pennsylvania and Oklahoma. The recall was initiated on February 18, 2015, and was terminated on August 18, 2015. The FDA classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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 (5)

  • NDC 61786-0055-01
  • Lot # B00484449-100914
  • Lot # B0062349-121914
  • Lot # B006655-011415
  • Expiration Date: 04/01/2016

Distribution

Distributed in 2 states:

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