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Recall Observatory FDA recall evidence

Drug product

Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01.

D-449-2013

April 01, 2013

Class II

Product summary

Firm
Lloyd Inc. of Iowa
Event
Event 65154
Status
Terminated
Classification
Class II
Quantity
61,347 Bottles
Official record key
drug-enforcement:D-449-2013

Official wording

Reason: cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Code information: Lot #: 1095213, 1095214, Exp Apr-13; 1097733, Exp Jul-13; 1098540, Exp Aug-13.

Distribution pattern: The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations