Drug recall
LO/OVRAL-28 (norgestrel and ethinyl estradiol tablets), 21 white tablets each containing 0.3 mg norgestrel…
FDA recall event 60765 · Class II · Pfizer Inc.
Key facts
| Event ID | 60765 |
|---|---|
| Recall numbers | D-1188-2012, D-1189-2012 |
| Recalling firm | Pfizer Inc. |
| Product type | Drugs |
| Products | LO/OVRAL-28 (norgestrel and ethinyl estradiol tablets), 21 white tablets each containing 0.3 mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak…, Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg Tablets --- 21 white tablets, each containing 0.3 mg norgestrel with 0.03 mg ethinyl estradiol, and 7 pink inert tablets, Package contains 6 Pilpak… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Contraceptive Tablets Out of Sequence: some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. |
| Initiation date | Dec 28, 2011 |
| Termination date | Jul 6, 2018 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 2416101 |
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