Exact FDA event identifier

Event 76661

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

Event summary

Timeline bucket: January 27, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Pharmedium Services, 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

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

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466

D-0603-2017

Recall number: D-0603-2017
Initiated: January 27, 2017
Classification: Class III
Status: Terminated
Recalling firm: Pharmedium Services, LLC
Quantity: 3879 syringes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling; Label Mixup

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

Code information

Lot Numbers: 170110030M, 170110029M and 170070058M

Distribution pattern

Nationwide