Recalls / Class I
Class ID-0105-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot numbers: 005C16, 006C16, 007C16, Exp 02/2018
Why it was recalled
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.
Recalling firm
- Firm
- Arbor Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6 Concourse Pkwy, Suite 1800, Atlanta, Georgia 30328-6117
Distribution
- Quantity
- 16,932 cartons
- Distribution pattern
- CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
Timeline
- Recall initiated
- 2016-07-21
- FDA classified
- 2016-10-14
- Posted by FDA
- 2016-10-26
- Terminated
- 2017-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0105-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.