PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: October 26, 2016 Initiated: July 21, 2016 #D-0105-2017

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.

Details

Units Affected
16,932 cartons
Distribution
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Arbor Pharmaceuticals Inc.. Units affected: 16,932 cartons.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 26, 2016. Severity: Critical. Recall number: D-0105-2017.