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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97183

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

Open FDA event record

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

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