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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91381

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Spectrum Laboratory Products, Inc.

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 (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130

D-0179-2023
Recall number
D-0179-2023
Initiated
December 19, 2022
Classification
Class I
Status
Terminated
Quantity
1 bottle

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Code information

Lot # 1KG0865 EXP 31-Mar-2023

Distribution pattern

Nationwide in the USA, Puerto Rico and Canada

drug · product 2 of 2

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.

D-0180-2023
Recall number
D-0180-2023
Initiated
December 19, 2022
Classification
Class I
Status
Terminated
Quantity
7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Code information

Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023

Distribution pattern

Nationwide in the USA, Puerto Rico and Canada