Recall D-0180-2023
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.
Recall D-0180-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0180-2023 |
Event ID | 91381 |
Distribution | Nationwide in the USA, Puerto Rico and Canada |
Quantity | 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G |
Recall Reason | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product |
Drug Classification | Class I |
Drug Code Info | 20230201 |
Recall Initiation Date | 20221219 |
Report Date | 20230201 |
Classification Date | 20230125 |
Address | 755, 769 And 777 Jersey Ave New Brunswick, NJ 08901-3605 United States |
Recalling Firm | Spectrum Laboratory Products, Inc. |
Initial Notification | Letter |
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