🍔 Food 💊 Drugs 🏥 Medical Devices
Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14 Class II

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Franck's Lab Inc dba Trinity Care Solutions 20140515 Ongoing
Distributed: Florida
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DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France Class III

Reason: Stability Data Does Not Support Expiry

Estee Lauder Inc 20140606 Terminated
Distributed: Nationwide
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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 Class II

Reason: Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg

Shamrock Medical Solutions Group LLC 20110927 Terminated
Distributed: Product was shipped to the following states: CO, MA, OH, TX & WY.
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Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01 Class II

Reason: 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

Shamrock Medical Solutions Group LLC 20110927 Terminated
Distributed: Product was shipped to the following states: CO, MA, OH, TX & WY.
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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 Class II

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

Shamrock Medical Solutions Group LLC 20110927 Terminated
Distributed: Product was shipped to the following states: CO, MA, OH, TX & WY.
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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 Class I

Reason: Labeling: Label Mix up; product labeled did not indicated Extended Release

Shamrock Medical Solutions Group LLC 20110927 Terminated
Distributed: Product was shipped to the following states: CO, MA, OH, TX & WY.
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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 Class I

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

Shamrock Medical Solutions Group LLC 20110927 Terminated
Distributed: Product was shipped to the following states: CO, MA, OH, TX & WY.
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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 Class I

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

Shamrock Medical Solutions Group LLC 20110927 Terminated
Distributed: Product was shipped to the following states: CO, MA, OH, TX & WY.
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Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540. Class III

Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Sandoz Inc 20140711 Terminated
Distributed: Nationwide
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Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1. Class III

Reason: Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

X-Gen Pharmaceuticals Inc. 20140717 Terminated
Distributed: Nationwide
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