July 2017 FDA Recall Drug by Precision Dose Inc.
D-1037-2017 - Labeling Error

This Class II drug recall was voluntarily initiated by Precision Dose Inc. on July 5, 2017 for the product Drug. The FDA reported the reason for recall as labeling error. The product was distributed in OH and CT and the recall is currently terminated.

Recall Number: D-1037-2017

Reason for Recall
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Initiated
07-05-2017
Reported
08-09-2017
Quantity
480 (5mL) unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77732
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.
Precision Dose 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.
OH and CT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2018
Product Description About Product Description
Full technical description of the product.
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

Batch or Lot Expiration Information

Lot# : 500326, Exp. 6/30/2018