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
Reported: July 24, 2013 Initiated: June 21, 2013 #D-805-2013
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.
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 10,848 cartons
- Distribution
- Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Incorporated. Units affected: 10,848 cartons.
Why was this product recalled? ▼
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2013. Severity: Moderate. Recall number: D-805-2013.
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