Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged b... — FDA record D-0179-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Classification
Class I
Recalling firm
Spectrum Laboratory Products, Inc.
Quantity
1 bottle
Agency-reported status
Terminated
Source record identifier
D-0179-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot # 1KG0865 EXP 31-Mar-2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA, Puerto Rico and Canada

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Feb 1, 2023
Recall initiation date
Dec 19, 2022
Center classification date
Jan 25, 2023
Termination date
Aug 19, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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