Shamrock Medical Solutions Group LLC
Complete recall history across all FDA and CPSC categories — 6 total recalls
Shamrock Medical Solutions Group LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (6)
FDA drug safety enforcement actions by Shamrock Medical Solutions Group LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 27, 2011 | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to cont... | Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually... | Class II |
| Sep 27, 2011 | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx... | Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trime... | Class II |
| Sep 27, 2011 | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiam... | Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiaz... | Class I |
| Sep 27, 2011 | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as M... | Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually... | Class I |
| Sep 27, 2011 | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta... | Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg inst... | Class II |
| Sep 27, 2011 | metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate... | Labeling: Label Mix up; product labeled did not indicated Extended Release | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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