Enforcement Report - Week of January 9, 2013
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Product Detail
| Product Description | Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A. |
|---|---|
| Recall Number | D-107-2013 |
| Classification | Class II |
| Code Info | LOT # 18262A8 Exp. 09/13 |
| Product Distributed Qty | 28, 524 bottles |
| Reason For Recall | Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. |
Event Detail
| Event Id | 63791 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Abbott Laboratories |
| City | Abbott Park |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide and Puerto Rico |
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