RemedyRepack Recalls Ketorolac Tromethamine Injections Due to Particulate Matter
RemedyRepack Inc. is recalling 75 vials of Ketorolac Tromethamine 30 mg/1mL injections distributed in Oklahoma and Louisiana due to the presence of small black particles.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
RemedyRepack Inc. has issued a recall for 75 vials of Ketorolac Tromethamine 30 mg/1mL Injections for I.V./I.M. Use. The product was repackaged by RemedyRepack Inc. in Indiana, Pennsylvania, and distributed in Oklahoma and Louisiana. The recall was initiated because small black particles were noticed during routine visual inspection of retained samples.
The affected product is identified by NDC 70518-1239-00. The specific lots involved are B0444562-060118 (expiration date 04/2020) and B0537002-112118 (expiration date 07/2020). The medication is labeled for prescription use only.
Healthcare providers and patients should stop using the affected product and contact RemedyRepack Inc. for further instructions. The U.S. Food and Drug Administration has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Injectable Medication
- Hazard
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 # B0444562-060118
- exp. 04/2020
- B0537002-112118
- exp 07/2020
Distribution
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