Class II · Moderate risk
Docusate Sodium 250 mg
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Docusate Calcium Softgel Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
0904-5779-60
Compare with the code on your package — it is the most precise check available.
Drug: Docusate
- Recalling firm
- Shamrock Medical Solutions Group LLC
- NDC code
- 00904-5779-60
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1451-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Docusate recalls
See all
Class II · Moderate risk
OneLAX Docusate Sodium Liquid
CGMP Deviations
Class II · Moderate risk
Docu Liquid
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Sankaijo BOTANICAL LAXATIVE
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Other recalls by Shamrock Medical Solutions Group LLC
All 2011 recalls
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Class I · High risk
metFORMIN ER Tablets
Labeling: Label Mix up; product labeled did not indicated Extended Release
Class I · High risk
Oxycodone HCl Oral Concentrate
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
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