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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83339

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

Open FDA event record

Event summary

Timeline bucket
July 12, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
H J Harkins Company Inc dba Pharma Pac

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

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01

D-1580-2019
Recall number
D-1580-2019
Initiated
July 12, 2019
Classification
Class II
Status
Terminated
Quantity
97 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Code information

Lot #: NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp 05/20; NPD16RP, Exp 06/20; NPD17RP, Exp 01/21; NPD18RP, Exp 02/21

Distribution pattern

Distributed in California