Exact FDA event identifier

Event 97183

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

Event summary

Timeline bucket: July 09, 2025
Product types: Drug
Classifications: Class II and Class III
Statuses: Completed
Recalling firm wording: Imprimis NJOF, LLC

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

D-0535-2025

Recall number: D-0535-2025
Initiated: July 09, 2025
Classification: Class II
Status: Completed
Recalling firm: Imprimis NJOF, LLC
Quantity: 6,880 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Code information

Lot: 24DEC017, Exp. 07/12/2025.

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

D-0536-2025

Recall number: D-0536-2025
Initiated: July 09, 2025
Classification: Class III
Status: Completed
Recalling firm: Imprimis NJOF, LLC
Quantity: 2,890 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Code information

Lot: 25MAR032, Exp. 07/16/2025.

Distribution pattern

Nationwide in the USA