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Recall Observatory FDA recall evidence

Drug product

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

D-318-2013

March 12, 2013

Class III

Product summary

Firm
L. Perrigo Co.
Event
Event 64729
Status
Terminated
Classification
Class III
Quantity
21,667 bottles
Official record key
drug-enforcement:D-318-2013

Official wording

Reason: Failed Impurities/Degradation Specifications: 3 month stability testing.

Code information: 12K714 exp. 12/13, 12K715 exp. 12/13

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications