FDA-Drug2016-10-26Class I
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.
Arbor Pharmaceuticals Inc.
Hazard
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.
Sold states
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Affected count
16,932 cartons
Manufactured in
6 Concourse Pkwy, Suite 1800, Atlanta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0105-2017Don't want to check this manually?
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