July 2016 FDA Recall Drug by Arbor Pharmaceuticals Inc.
D-0105-2017 - Defective Container

This Class I drug recall was voluntarily initiated by Arbor Pharmaceuticals Inc. on July 21, 2016 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed in CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV. and the recall is currently terminated.

Recall Number: D-0105-2017

Reason for Recall
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Initiated
07-21-2016
Reported
10-26-2016
Quantity
16,932 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74857
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.
Arbor 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of the product.
Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.

Batch or Lot Expiration Information

Lot# Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018