openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
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drug · product 1 of 1
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.
Labeling or packagingreason.labeling_packaging · v1.0.0
Incomplete seal
These labels are deterministic app interpretations, not FDA categories.
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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.
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.
