Drug product
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01
D-0568-2016
Product summary
- Event
- Event 72893
- Status
- Terminated
- Classification
- Class III
- Quantity
- 29,827 bottles
- Official record key
drug-enforcement:D-0568-2016
Official wording
Reason: Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Code information: Lot #: 5EA46, Exp 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled