RecallRadar

FDA Drug recall D-0105-2017

Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distri…

On 2016-10-26 the FDA classified a Class I recall of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distri… by Arbor Pharmaceuticals, citing 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….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0105-2017
ClassificationClass I
Statusterminated
Initiated2016-07-21
Published2016-10-26
Last updated2026-09-13 11:51 UTC
CompanyArbor Pharmaceuticals
DistributionCA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA, WV

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

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0105-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.