CLASS II Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Docusate Calcium Softgel Capsules, 240 mg recalled
Shamrock Medical Solutions Group is recalling Docusate Calcium Softgel Capsules, 240 mg, distributed in Colorado, Massachusetts, Ohio, Texas, Wyoming. The recall was initiated on 27 Sep 2011 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1451-2014
- FDA event ID
- 64611
- Recalling firm
- Shamrock Medical Solutions Group, Lewis Center, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2011
- FDA classified
- 23 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 27 Sep 2011 | Recall initiated by company | |
| 23 Jul 2014 | Classified by FDA | +1030 days |
| 30 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Product was shipped to the following states: CO, MA, OH, TX & WY.
Questions about this recall
Why was it recalled?
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Which lots are affected?
Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60
Where was it sold?
Product was shipped to the following states: CO, MA, OH, TX & WY.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 64611This product is part of a recall event; the main page for the event is metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS I | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS II | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
More recalls from Shamrock Medical Solutions Group
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
Other Docusate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Docusate Sodium 250 mg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Sankaijo Botanical Laxative (docusate sodium 8.33 mg recalledSankaijo | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Docusate Sodium, 100mg softgels recalled by Rx Pak Division of McKesson | Rx Pak Division of McKesson | Packaging Defects | Nationwide |
| Drug | CLASS I | Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding | US Compounding | Sterility | TX |
| Drug | CLASS II | Docusate Calcium, Capsule, 240 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |