February 2016 FDA Recall Drug by Pharmakon Pharmaceuticals
D-0871-2016 - Super-Potent Drug

This Class I drug recall was voluntarily initiated by Pharmakon Pharmaceuticals on February 11, 2016 for the product Drug. The FDA reported the reason for recall as super-potent drug. The product was distributed in IN and IL and the recall is currently terminated.

Recall Number: D-0871-2016

Reason for Recall
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Initiated
02-11-2016
Reported
06-01-2016
Quantity
75 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73297
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IN and IL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2017
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

Batch or Lot Expiration Information

Lot# : E52418EV11C, Exp 03/19/2016