FDA Recall D-0105-2017
Arbor Pharmaceuticals Inc. · Atlanta, GA
Class I — life-threatening Terminated 186 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0105-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
- Recall initiated
- 2016-07-21
- Classified by FDA Center
- 2016-10-14
- FDA published
- 2016-10-26
- Terminated
- 2017-01-23
- Recalling firm
- Arbor Pharmaceuticals Inc.
- Firm location
- Atlanta, GA