Drug recall
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only…
FDA recall event 91381 · Class I · Spectrum Laboratory Products, Inc.
Key facts
| Event ID | 91381 |
|---|---|
| Recall numbers | D-0179-2023, D-0180-2023 |
| Recalling firm | Spectrum Laboratory Products, Inc. |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product |
| Initiation date | Dec 19, 2022 |
| Report date | Feb 1, 2023 |
| Termination date | Aug 19, 2025 |
| City | New Brunswick |
| State | NJ |
| Country | United States |
| FEI number | 2246824 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: