Drug product
FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
D-490-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-490-2014
Official wording
Reason: Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014.
Code information: FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) has the following code Pedigree: AD54553_1, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled