D-0105-2017 Class I Terminated
FDA drug recall D-0105-2017 was initiated by Arbor Pharmaceuticals Inc. on July 21, 2016 and is designated Class I. 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. The recall status is terminated (terminated January 23, 2017). Affected quantity: 16,932 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- October 26, 2016
- Initiation Date
- July 21, 2016
- Termination Date
- January 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,932 cartons
Product Description
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 Pattern
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Code Information
Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018