December 2019 FDA Recall Drug by Remedyrepack Inc.
D-0867-2020 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Remedyrepack Inc. on December 27, 2019 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in Product distributed in OK and LA. and the recall is currently terminated.

Recall Number: D-0867-2020

Reason for Recall
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Initiated
12-27-2019
Reported
02-19-2020
Quantity
75 1 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84900
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed in OK and LA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020