The Recall Desk

FDA (Drugs) recall action 64611

Shamrock Medical Solutions Group LLC recalled 6 products on 2014-07-30

The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2014-07-30
Critical
2
Units
—

Why these products were recalled

Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–6 of 6

  • CriticalFDA (Drugs)··2014-07-30

    Shamrock Medical Recalls Mislabelled Diltiazem Capsules Packaged as Thiamine

    Shamrock Medical Solutions is recalling Diltiazem HCl capsules that were incorrectly labeled as Thiamine. The error could lead to patients receiving the wrong medication.

    Product
    Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
    Category
    Distribution
    5 states
  • SevereFDA (Drugs)··2014-07-30

    Shamrock Medical Recalls Mislabelled Pramipexole Tablets Packaged as Nebivolol

    Shamrock Medical Solutions is recalling Pramipexole Dihydrochloride tablets that were incorrectly labeled as Nebivolol. The error poses a risk of patients receiving the wrong medication.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01
    Category
    Distribution
    5 states
  • CriticalFDA (Drugs)··2014-07-30

    Oxycodone HCl Oral Concentrate Recalled Due to Incorrect Morphine Labeling

    Shamrock Medical Solutions is recalling Oxycodone HCl Oral Concentrate that was incorrectly labeled as Morphine Sulfate. The product was distributed to Colorado, Massachusetts, Ohio, Texas, and Wyoming.

    Product
    Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36
    Category
    Distribution
    5 states
  • ModerateFDA (Drugs)··2014-07-30

    Shamrock Recalls Mislabelled Sulfamethoxazole and Trimethoprim Tablets

    Shamrock Medical Solutions Group LLC is recalling Sulfamethoxazole and Trimethoprim tablets due to a labeling error where 800 mg/160 mg tablets were labeled as 400 mg/80 mg.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Distribution
    5 states
  • SevereFDA (Drugs)··2014-07-30

    Shamrock Recalls Metformin ER Tablets Labeled as Immediate Release

    Shamrock Medical Solutions is recalling metformin ER tablets that were incorrectly labeled as immediate release. The mislabeling could lead to incorrect dosing.

    Product
    metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
    Category
    Distribution
    5 states
  • ModerateFDA (Drugs)··2014-07-30

    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.

    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
    Category
    Distribution
    5 states