February 2015 FDA Recall Drug by Remedyrepack Inc.
D-0484-2015 - Crystallization

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on February 18, 2015 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed in PA, OK. and the recall is currently terminated.

Recall Number: D-0484-2015

Reason for Recall
Crystallization
Initiated
02-18-2015
Reported
04-15-2015
Quantity
25 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70549
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
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.
PA, OK.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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