April 2016 FDA Recall Drug by A-s Medication Solutions Llc.
D-0839-2016 - Labeling

This Class III drug recall was voluntarily initiated by A-s Medication Solutions Llc. on April 22, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Virginia and the recall is currently terminated.

Recall Number: D-0839-2016

Reason for Recall
Labeling: Not elsewhere classified - count on the label was incorrect.
Initiated
04-22-2016
Reported
05-11-2016
Quantity
2730 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74011
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A-S Medication Solutions 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Virginia
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-20-2016
Product Description About Product Description
Full technical description of the product.
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0

Batch or Lot Expiration Information

Lot# 6050129, Exp 05/31/17