Drug Enforcement D-318-2013

Failed Impurities/Degradation Specifications: 3 month stability testing.

Status

Terminated

Classification

Class III

Report Date

May 15, 2013

Termination Date

July 24, 2013

Product Information

Product description
Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
Product quantity
21,667 bottles
Reason for recall
Failed Impurities/Degradation Specifications: 3 month stability testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
L. Perrigo Co.
Address
515 Eastern Ave, N/A

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

Codes & Dates

Recall number
D-318-2013
Event ID
64729
Recall initiation date
March 12, 2013
Center classification date
May 9, 2013
Code info
12K714 exp. 12/13, 12K715 exp. 12/13
More code info
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