Why it was recalled
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
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
Lot numbers, UPCs & expiration codes
Lot #: 5EA46, Exp 02/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0568-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 18, 2015
- FDA report date
- Jan 20, 2016
- Quantity
- 29,827 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- National Vitamin Co Inc
Original FDA data
Every field from FDA enforcement report D-0568-2016, exactly as published.
Show all FDA fields
- City
- Casa Grande
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 72893
- Address
- 1145 W Gila Bend Hwy
- Code information
- Lot #: 5EA46, Exp 02/17
- Postal code
- 85122-4308
- Report date
- Jan 20, 2016
- Product type
- Drugs
- Recall number
- D-0568-2016
- Classification
- Class III
- Recalling firm
- National Vitamin Co Inc
- Product quantity
- 29,827 bottles
- Termination date
- May 3, 2016
- Reason for recall
- Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 18, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2016