Enforcement Report - Week of October 3, 2012
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Event Detail
| Event ID | 62674 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Abbott Laboratories |
| City | Abbott Park |
| State | IL |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90. | 18265A8, Exp 09/20/2013 | Class II | 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. | 53,448 Bottles | D-1694-2012 |
| Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90. | Lot: 18353A8, Exp 08/31/2013 | Class II | 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. | 42,596 Bottles | D-1695-2012 |
| Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90 | Lot: 18355A8, Exp. 09/26/13 | Class II | 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. | 40,464 Bottles | D-1696-2012 |
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