D-0180-2023 Class I Terminated
FDA drug recall D-0180-2023 was initiated by Spectrum Laboratory Products, Inc. on Dec 19, 2022 and is designated Class I. Reason for recall: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product The recall status is terminated (terminated Aug 19, 2025). Affected quantity: 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 1, 2023
- Initiation Date
- Dec 19, 2022
- Termination Date
- Aug 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
Product Description
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.
Reason for Recall
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Distribution Pattern
Nationwide in the USA, Puerto Rico and Canada
Code Information
Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0180-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026