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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73778

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

Open FDA event record

Event summary

Timeline bucket
March 16, 2016
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Actavis Pharma 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

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

D-1060-2016
Recall number
D-1060-2016
Initiated
March 16, 2016
Classification
Class III
Status
Terminated
Recalling firm
Actavis Pharma Inc
Quantity
447,150 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

Code information

Lot #s: a) 626487, Exp. 3/31/2016, 628181, Exp. 6/30/2016, 629827, Exp. 9/30/2016, 630495, Exp. 10/31/2016, 632266, Exp. 2/28/2017, 633683 Exp. 4/30/2017, 347742, Exp. 09/30/2017; b) 626487, Exp. 3/31/2016, 627438, 628080, Exp. 5/31/2016, 628181, 628491, Exp. 6/30/2016, 628634, Exp. 7/31/2016, 629141 Exp. 8/31/2016, 629827, Exp. 9/30/2016, 630495, Exp. 10/31/2016, 631528, Exp. 12/31/2016, 632266, Exp. 2/28/2017, 347613, Exp. 9/30/2017, 348175, Exp. 10/31/2017; c) 628398 Exp. 6/30/2016, 630495, Exp.10/31/ 2016, 630511, Exp. 10/31/2016 347361, Exp. 8/31/2017

Distribution pattern

Nationwide and Puerto Rico

Field note

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