Home / Recalls / Arbor Pharmaceuticals Inc. / D-0105-2017

D-0105-2017 Class I Terminated

Recalled by Arbor Pharmaceuticals Inc. — Atlanta, GA

Recall Details

Product Type: Drugs
Report Date: October 26, 2016
Initiation Date: July 21, 2016
Termination Date: January 23, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,932 cartons

Product Description

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.

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.

Distribution Pattern

CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.

Code Information

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