Recalls / Class II
Class IID-805-2013
Product
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
- Affected lot / code info
- Lot: LF01213A, Exp. 02/14
Why it was recalled
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 10,848 cartons
- Distribution pattern
- Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Timeline
- Recall initiated
- 2013-06-21
- FDA classified
- 2013-07-17
- Posted by FDA
- 2013-07-24
- Terminated
- 2014-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-805-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.