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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75695

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 02, 2016
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fallon Wellness Pharmacy, L.L.C.

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

2 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 2

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

D-0173-2017
Recall number
D-0173-2017
Initiated
November 02, 2016
Classification
Class II
Status
Terminated
Quantity
10 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.

Code information

Lot #: 09192016@41,09192016@69, Exp 11/04/2016

Distribution pattern

NY

drug · product 2 of 2

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

D-0174-2017
Recall number
D-0174-2017
Initiated
November 02, 2016
Classification
Class II
Status
Terminated
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.

Code information

Lot #: 09202016@8, Exp 11/04/2016

Distribution pattern

NY