Drug product
Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
D-1696-2012
Product summary
- Event
- Event 62674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,464 Bottles
- Official record key
drug-enforcement:D-1696-2012
Official wording
Reason: 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.
Code information: Lot: 18355A8, Exp. 09/26/13
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.