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.
FDA recall notice · announced October 26, 2016 · Arbor Pharmaceuticals
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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.
Notes
Distribution: CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Lot/code information: Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018
Quantity: 16,932 cartons
Status: Terminated
Products in this recall event:
- 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 24 (D-0105-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.