Recalls / Class II
Class IID-0887-2017
Product
Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet per box, Distributed By Perrigo, Allegan, MI 49010. NDC 0113-2003-12
- Brand name
- Option 2
- Generic name
- Levonorgestrel
- Active ingredient
- Levonorgestrel
- Route
- Oral
- NDC
- 0113-2003
- FDA application
- ANDA202334
- Affected lot / code info
- Lot #: 6LV1114, 6LV1115, 6LV1116, 6MV0976, 6MV0977, Exp.04/18; 7AV1173, 7AV1175, 7AV1176, Exp.07/18.
Why it was recalled
Defective Container: Carton is missing the tablet blister strip and tablet.
Recalling firm
- Firm
- L. Perrigo Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 181,776 (units/eaches)
- Distribution pattern
- Nationwide in the US and Canada
Timeline
- Recall initiated
- 2017-06-01
- FDA classified
- 2017-06-06
- Posted by FDA
- 2017-06-14
- Terminated
- 2017-11-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0887-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.