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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79265

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
SCA Pharmaceuticals, 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

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

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028

D-0603-2018
Recall number
D-0603-2018
Initiated
February 22, 2018
Classification
Class III
Status
Terminated
Recalling firm
SCA Pharmaceuticals, LLC.
Quantity
480 syringes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018

Code information

lot 1217000213, exp 03/27/2019

Distribution pattern

GA, NE & PA