Drug Enforcement D-805-2013

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

Status

Terminated

Classification

Class II

Report Date

July 24, 2013

Termination Date

January 29, 2014

Product Information

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
Product quantity
10,848 cartons
Reason for recall
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.

Location & Firm

Recalling firm
Sandoz Incorporated
Address
2555 W Midway Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-805-2013
Event ID
65511
Recall initiation date
June 21, 2013
Center classification date
July 17, 2013
Code info
Lot: LF01213A, Exp. 02/14
More code info
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