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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74857

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 21, 2016
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Arbor Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

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.

D-0105-2017
Recall number
D-0105-2017
Initiated
July 21, 2016
Classification
Class I
Status
Terminated
Quantity
16,932 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete seal

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.