March 2015 FDA Recall Drug by Safecor Health, Llc
D-0661-2016 - Defective Container

This Class II drug recall was voluntarily initiated by Safecor Health, Llc on March 2, 2015 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-0661-2016

Reason for Recall
Defective Container: Confirmed customer complaints of leaking bottles.
Initiated
03-02-2015
Reported
02-17-2016
Quantity
3,532 amber bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72947
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.
Safecor Health, LLC
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.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-25-2016
Product Description About Product Description
Full technical description of the product.
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.

Batch or Lot Expiration Information

Lot# 846881; Exp 01/16