The Recall Desk

FDA (Drugs) recall action 91381

Spectrum Laboratory Products, Inc. recalled 2 products on 2023-02-01

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-02-01
Critical
0
Units
1

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2023-02-01

    Epinephrine Active Pharmaceutical Ingredient Recalled for Discoloration

    Spectrum Laboratory Products is recalling Epinephrine API lot 1KG0865 due to discoloration that may compromise product effectiveness. The product was distributed nationwide in the USA, Puerto Rico, and Canada.

    Product
    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2023-02-01

    Epinephrine API Recalled for Discoloration and Reduced Efficacy

    Spectrum Laboratory Products recalls Epinephrine (L-Adrenaline) USP in multiple lot sizes due to discoloration that could reduce the product's effectiveness. The recall affects shipments distributed nationwide in the USA, Puerto Rico, and Canada.

    Product
    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.
    Category
    Distribution
    1 state