The Recall Desk
ModerateFDA (Drugs)·D-0568-2016·Announced 2016-01-20

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.

What this means for you

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
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.

Same manufacturer · National Vitamin Co Inc

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