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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 51880

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

Open FDA event record

Event summary

Timeline bucket
March 09, 2012
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Pack Pharmaceuticals

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

Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.

D-1422-2012
Recall number
D-1422-2012
Initiated
March 09, 2012
Classification
Class III
Status
Terminated
Recalling firm
Pack Pharmaceuticals
Quantity
4,848 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling Illegible: Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.

Code information

Lot #: : PUB1040, Exp 08/2015

Distribution pattern

Nationwide