Drug Enforcement D-077-2013

cGMP Deviations; does not meet in process specification requirements

Status

Terminated

Classification

Class II

Report Date

December 12, 2012

Termination Date

November 14, 2013

Product Information

Product description
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Product quantity
31,252/100-tablet bottles
Reason for recall
cGMP Deviations; does not meet in process specification requirements
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

Location & Firm

Recalling firm
Lloyd Inc. of Iowa
Address
604 W Thomas Ave, N/A

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

Codes & Dates

Recall number
D-077-2013
Event ID
62511
Recall initiation date
July 9, 2012
Center classification date
December 3, 2012
Code info
Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012
More code info
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