FDA recall D-0105-2017

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.

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

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

Key facts

Status

Terminated

Initiation date

2016-07-21

Report date

2016-10-26

Termination date

2017-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0105-2017