Why it was recalled
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Product description
Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
Lot numbers, UPCs & expiration codes
Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60
Where it was sold
Product was shipped to the following states: CO, MA, OH, TX & WY.
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-1451-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2011
- FDA report date
- Jul 30, 2014
- Quantity
- 99/240 mg softgel caps
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shamrock Medical Solutions Group LLC
Original FDA data
Every field from FDA enforcement report D-1451-2014, exactly as published.
Show all FDA fields
- City
- Lewis Center
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 64611
- Address
- 741 Radio Dr
- Code information
- Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60
- Postal code
- 43035-7134
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1451-2014
- Classification
- Class II
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Product quantity
- 99/240 mg softgel caps
- Termination date
- Jul 31, 2014
- Reason for recall
- Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Recall initiation date
- Sep 27, 2011
- Initial firm notification
- Telephone
- Center classification date
- Jul 23, 2014