Drug Enforcement D-084-2013

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
Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Product quantity
1,902,957 tablets
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-084-2013
Event ID
62511
Recall initiation date
July 9, 2012
Center classification date
December 3, 2012
Code info
Lot #HE35311
More code info
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