Drug 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.
D-0105-2017
Product summary
- Event
- Event 74857
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,932 cartons
- Official record key
drug-enforcement:D-0105-2017
Official wording
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.
Code information: Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018
Distribution pattern: CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Derived failure modes
-
Labeling or packaging
Incomplete seal