Drug product
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
D-601-2013
Product summary
- Event
- Event 63988
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19,944 bottles
- Official record key
drug-enforcement:D-601-2013
Official wording
Reason: Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Code information: Lot 12G468, Exp. 07/2014.
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mixup