Drug 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
D-0179-2023
Product summary
- Event
- Event 91381
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 bottle
- Official record key
drug-enforcement:D-0179-2023
Official wording
Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Code information: Lot # 1KG0865 EXP 31-Mar-2023
Distribution pattern: Nationwide in the USA, Puerto Rico and Canada
Derived failure modes
-
Unknown
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product