FDA Drug Recalls

Recalls / Class III

Class IIID-318-2013

Product

Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,

Affected lot / code info
12K714 exp. 12/13, 12K715 exp. 12/13

Why it was recalled

Failed Impurities/Degradation Specifications: 3 month stability testing.

Recalling firm

Firm
L. Perrigo Co.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
515 Eastern Ave, N/A, Allegan, Michigan 49010-9070

Distribution

Quantity
21,667 bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2013-03-12
FDA classified
2013-05-09
Posted by FDA
2013-05-15
Terminated
2013-07-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-318-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.