FDAClass IIJuly 24, 2013

Estarylla recall

Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma…

Why was Estarylla recalled?

Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: LF01213A, Exp. 02/14

Product
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma…
Recalling firm
Sandoz Incorporated
Quantity
10,848 cartons
Distribution
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Recall date
July 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls