Drug recall
Tylenol(R) Cold Multi-Symptom Nighttime Rapid Release Gels 24 RR Gelcaps, NDC 50580-395-24
FDA recall event 59721 · Class II · Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Key facts
| Event ID | 59721 |
|---|---|
| Recall numbers | D-381-2012, D-382-2012, D-383-2012 |
| Recalling firm | Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. |
| Product type | Drugs |
| Products | Tylenol(R) Cold Multi-Symptom Nighttime Rapid Release Gels 24 RR Gelcaps, NDC 50580-395-24, Tylenol(R) Cold Multi-Symptom Rapid Release Gels Day/Night 12+8 RR Gelcaps, NDC 50580-396-20, Tylenol(R) Cold Multi-Symptom Rapid Release Gels Day/Night 36+24 RR Gelcaps, NDC 50580-396-60 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products; the level of Chlorpheniramine Ammonio Acetate (CPAA) was slightly higher than expected in some TYLENOL(R) Cold Multi-Symptom Nighttime Rapid Release Gelcaps. |
| Initiation date | Aug 15, 2011 |
| Termination date | Apr 11, 2013 |
| City | Fort Washington |
| State | PA |
| Country | United States |
| FEI number | 2510184 |
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