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.
Reported: October 26, 2016 Initiated: July 21, 2016 #D-0105-2017
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.
Details
- Recalling Firm
- Arbor Pharmaceuticals Inc.
- Units Affected
- 16,932 cartons
- Distribution
- CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arbor Pharmaceuticals Inc.. Units affected: 16,932 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 26, 2016. Severity: Critical. Recall number: D-0105-2017.
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