Drug recall
Allergenics - Other (most recent batch of Mixture Of Standardized Grass Mix # 4-S, Lot #0003127428, 100,000…
FDA recall event 80409 · Class III · Alk-abello, Inc.
Key facts
| Event ID | 80409 |
|---|---|
| Recall numbers | B-0746-2018 |
| Recalling firm | Alk-abello, Inc. |
| Product type | Biologics |
| Products | Allergenics - Other (most recent batch of Mixture Of Standardized Grass Mix # 4-S, Lot #0003127428, 100,000 BAU/mL in a 5 mL Scratch Test Vial (STV) manufactured in Small Volume Production (SVP)) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Misbranded Allergenic Extract was distributed. |
| Initiation date | May 30, 2018 |
| Report date | Aug 29, 2018 |
| Termination date | Aug 20, 2018 |
| City | Port Washington |
| State | NY |
| Country | United States |
| FEI number | 2431784 |
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: