RemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization

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

• crystallization

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.

Distribution

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