Arbor Pharmaceuticals Inc. recalls Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count bl…

Recall date

July 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0105-2017

FDA classification

Class I

Brand / firm

Arbor Pharmaceuticals Inc.

Sold / distributed

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

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.