Drug Enforcement D-152-2013

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

Status

Terminated

Classification

Class III

Report Date

February 13, 2013

Termination Date

May 7, 2013

Product Information

Product description
Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ
Product quantity
17,188 cartons containing 3 cards each.
Reason for recall
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

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-152-2013
Event ID
64118
Recall initiation date
January 22, 2013
Center classification date
February 6, 2013
Code info
LF01215A, Exp 02/2014
More code info
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