Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by S
Summary
The FDA issued a Class I for Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuu by Spectrum Laboratory Products, Inc.. Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product.
Details
Source
Drug Recall
External ID
D-0179-2023
Action Date
2023-02-01
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # 1KG0865 EXP 31-Mar-2023
Quantity Affected: 1 bottle
Reason for Recall
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Distribution
Nationwide in the USA, Puerto Rico and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-19
Company
New Brunswick, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Spectrum Laboratory Products, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spectrum Laboratory Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spectrum Laboratory Products, Inc. have FDA actions?
Spectrum Laboratory Products, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0179-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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