Status
Terminated
Drug Enforcement D-0180-2023
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Classification
Class I
Report Date
February 1, 2023
Termination Date
August 19, 2025
Product Information
- 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.
- Product quantity
- 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
- Reason for recall
- Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA, Puerto Rico and Canada
Location & Firm
- Recalling firm
- Spectrum Laboratory Products, Inc.
- Address
-
755, 769 And 777 Jersey Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0180-2023
- Event ID
- 91381
- Recall initiation date
- December 19, 2022
- Center classification date
- January 25, 2023
- Code info
- Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023
- More code info
- —