Drug 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
D-805-2013
Product summary
- Event
- Event 65511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,848 cartons
- Official record key
drug-enforcement:D-805-2013
Official wording
Reason: Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Code information: Lot: LF01213A, Exp. 02/14
Distribution pattern: Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Derived failure modes
-
Unknown
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.