Recall Enforment Report D-1695-2012

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Abbott Laboratories, originally initiated on 07-19-2012 for the product Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90. The product was recalled due to defective container: a number of synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1695-201207-19-201210-03-2012Class II42,596 BottlesSynthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.Terminated
D-1696-201207-19-201210-03-2012Class II40,464 BottlesSynthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.Terminated
D-1694-201207-19-201210-03-2012Class II53,448 BottlesSynthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0074-3727Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-4341Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-4552Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-5182Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-6594Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-6624Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-7068Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-7069Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-7070Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-7148Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-7149Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug
0074-9296Synthroid Levothyroxine SodiumTabletOralAbbvie Inc.Human Prescription Drug