August 2017 FDA Recall Drug by Remedyrepack Inc.
D-1176-2017 - Crystallization

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on August 22, 2017 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed in Product was distributed to one consignee in Louisiana. and the recall is currently terminated.

Recall Number: D-1176-2017

Reason for Recall
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Initiated
08-22-2017
Reported
10-04-2017
Quantity
40 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78146
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.
Product was distributed to one consignee in Louisiana.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-03-2018
Product Description About Product Description
Full technical description of the product.
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.

Batch or Lot Expiration Information

Lot# : a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017