Shamrock Medical Recalls Docusate Calcium Softgels Due to Labeling Error
Shamrock Medical Solutions is recalling Docusate Calcium Softgel Capsules because they were mislabeled as Docusate Sodium. The error involves a label mix-up for the specific active ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 II and involves a labeling error (mislabeling of the active ingredient) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Shamrock Medical Solutions Group LLC is recalling Docusate Calcium Softgel Capsules, 240 mg, OTC. The product was packaged and labeled to contain Docusate Sodium 240mg instead of the correct Docusate Calcium 240mg. This recall is due to a labeling mix-up regarding the active ingredient.
The affected product is identified by NDC 00904-5779-60, Lot # 002H79, and a Use By date of 06/19/2013. The product was manufactured by Major Pharmaceuticals in Livonia, MI, and repackaged by Shamrock Medical Solutions in Lewis Center, Ohio. The quantity is 99/240 mg softgel caps.
The product was shipped to Colorado, Massachusetts, Ohio, Texas, and Wyoming. Consumers should check their medication for the specific NDC, lot number, and expiration date listed above. If the product matches these details, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- 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
- Manufacturer
- Shamrock Medical Solutions Group LLC
- Hazard
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 (3)
- Lot #: 002H79
- Use By: 06/19/2013
- NDC: 00904-5779-60
Distribution
Part of a larger recall action
This product is one of 6 recalled by Shamrock Medical Solutions Group LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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