February 2015 FDA Recall Drug by Sca Pharmaceuticals
D-0965-2015 - Presence of particulate.

This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on February 24, 2015 for the product Drug. The FDA reported the reason for recall as presence of particulate.. The product was distributed in IN, AR, MO, MN and the recall is currently terminated.

Recall Number: D-0965-2015

Reason for Recall
Presence of particulate.
Initiated
02-24-2015
Reported
04-29-2015
Quantity
421 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70583
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.
SCA Pharmaceuticals
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.
IN, AR, MO, MN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-09-2016
Product Description About Product Description
Full technical description of the product.
Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16

Batch or Lot Expiration Information

Lot# Lot: 20141223@20