Life-Line Docusate Calcium Stool Softener Recalled for Labeling Error
National Vitamin Co Inc is recalling Life-Line Docusate Calcium stool softeners because they were mislabeled as Docusate Sodium.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a labeling error (mislabeling) rather than a contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
National Vitamin Co Inc is recalling 29,827 bottles of Life-Line Docusate Calcium Sodium Free Stool Softener, 240 mg each, 100 softgels per bottle. The recall is due to a labeling error where Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
The affected product is identified by Lot # 5EA46 and an expiration date of 02/17. The product was distributed nationwide. The NDC for the recalled product is 54629-0640-01.
Consumers should check their medication cabinets for this specific product and stop using it if they find it. They should contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement.
The recalled product
- 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
- Manufacturer
- National Vitamin Co Inc
- Category
- Drug — Stool Softener
- Hazard
- Affected units
- 29,827
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 5EA46
- Exp 02/17
Distribution
Distributed nationwide across the United States.
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