November 2015 FDA Recall Drug by Freedom Pharmaceuticals Inc
D-0573-2016 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Freedom Pharmaceuticals Inc on November 9, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0573-2016

Reason for Recall
Presence of Foreign Substance
Initiated
11-09-2015
Reported
01-27-2016
Quantity
(a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72854
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.
Freedom Pharmaceuticals 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-23-2016
Product Description About Product Description
Full technical description of the product.
Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.

Batch or Lot Expiration Information

Lot# : F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016