D-805-2013 Class II Terminated
FDA drug recall D-805-2013 was initiated by Sandoz Incorporated on June 21, 2013 and is designated Class II. Reason for recall: Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. The recall status is terminated (terminated January 29, 2014). Affected quantity: 10,848 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 24, 2013
- Initiation Date
- June 21, 2013
- Termination Date
- January 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,848 cartons
Product Description
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
Reason for Recall
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Distribution Pattern
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Code Information
Lot: LF01213A, Exp. 02/14