Multi-event December 2022 FDA Recall Drug by Spectrum Laboratory Products, Inc.

This Multi-event Class I drug recall was voluntarily initiated by Spectrum Laboratory Products, Inc. on December 19, 2022 for the product Drug. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0179-2023 TERMINATED D-0180-2023 TERMINATED

Recall Number: D-0179-2023

Reason for Recall
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Initiated
12-19-2022
Reported
02-01-2023
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91381
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spectrum Laboratory Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA, Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-19-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 1KG0865 EXP 31-Mar-2023

Recall Number: D-0180-2023

Reason for Recall
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Initiated
12-19-2022
Reported
02-01-2023
Quantity
7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91381
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Spectrum Laboratory Products, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA, Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-19-2025
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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