D-0568-2016 Class III Terminated
FDA drug recall D-0568-2016 was initiated by National Vitamin Co Inc on December 18, 2015 and is designated Class III. Reason for recall: Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. The recall status is terminated (terminated May 3, 2016). Affected quantity: 29,827 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 20, 2016
- Initiation Date
- December 18, 2015
- Termination Date
- May 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,827 bottles
Product Description
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
Reason for Recall
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Distribution Pattern
Nationwide
Code Information
Lot #: 5EA46, Exp 02/17