Drug recall
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only…
FDA recall event 79080 · Class III · ALLERGAN
Key facts
| Event ID | 79080 |
|---|---|
| Recall numbers | D-0413-2018 |
| Recalling firm | ALLERGAN |
| Product type | Drugs |
| Products | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label. |
| Initiation date | Feb 2, 2018 |
| Report date | Feb 21, 2018 |
| Termination date | Feb 7, 2019 |
| City | Madison |
| State | NJ |
| Country | United States |
| FEI number | 3013696134 |
At a glance
- 1–9 Products in this recall
- None 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: