Drug recall
femhrt (norethindrone acetate/ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, each pouch contains a 28-count…
FDA recall event 59518 · Class II · Warner Chilcott Company LLC
Key facts
| Event ID | 59518 |
|---|---|
| Recall numbers | D-906-2011 |
| Recalling firm | Warner Chilcott Company LLC |
| Product type | Drugs |
| Products | femhrt (norethindrone acetate/ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, each pouch contains a 28-count tablet blister card, packaged in 5 pouches per box, Rx only, Manufactured by: Warner Chilcott… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: Femhrt 0.5 mg/2.5 mcg (norethindrone acetate and ethinyl estradiol) tablets, lot# 505758A failed to meet dissolution specification for norethidnrone acetate… |
| Initiation date | Jul 28, 2011 |
| Termination date | Nov 15, 2012 |
| City | Fajardo |
| State | PR |
| Country | United States |
| FEI number | 2619635 |
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