Shamrock Medical Solutions Group LLC
Product Description: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
Status:Completed
City:Lewis Center
State:OH
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Telephone
Distribution Pattern:Product was shipped to the following states: CO, MA, OH, TX & WY.
Classification:Class I
Product Quantity:88/5 mg tablets
Reason For Recall:Labeling: Label Mix up; product labeled did not indicated Extended Release
Recall Initiation Date:20110927
Report Date:20140730

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride Recall

Get an alert when a recall is issued.

Questions & Answers

  • Question

    NEVER HAVE I BEEN SO SICK IN MY LIFE. VOMITING STOMACH BLEEDING DIZZY , HEADACHE , NO ENERGY, SICK ALL THE TIME.

    posted on October 5, 2015
  • Question

    Was that your first time taking Metforming, Carol?

    posted on October 6, 2015
  • Side Effects & Adverse Reactions

    Lactic Acidosis

    Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases.  Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found.

    The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications.  Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin.  In particular, treatment of the elderly should be accompanied by careful monitoring of renal function.  Metformin treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis.  Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin
    hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).

    The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The  patient and  the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.


    Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking metformin do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling. (See also PRECAUTIONS.)


    Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).


    Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking metformin, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin.  Such management often results in prompt reversal of symptoms and recovery. (See also CONTRAINDICATIONS and PRECAUTIONS.)

    Legal Issues

    There is currently no legal information available for this drug.

    FDA Safety Alerts

    There are currently no FDA safety alerts available for this drug.

    Manufacturer Warnings

    There is currently no manufacturer warning information available for this drug.

    FDA Labeling Changes

    There are currently no FDA labeling changes available for this drug.

    Uses


    Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

    History

    There is currently no drug history available for this drug.

    Other Information


    Metformin hydrochloride tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:


    Chemical Structure

    Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

    Metformin hydrochloride tablets, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone, and magnesium stearate. In addition, the coating for the 500 mg, 850 mg, and 1000 mg contains hypromellose and polyethylene glycol.

    Metformin Hydrochloride Manufacturers


    • Kaiser Foundation Hospitals
      Metformin Hydrochloride Tablet, Film Coated [Kaiser Foundation Hospitals]
    • Cardinal Health
      Metformin Hydrochloride Tablet, Film Coated [Cardinal Health]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
    • American Health Packaging
      Metformin Hydrochloride Tablet, Film Coated [American Health Packaging]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet, Film Coated [Remedyrepack Inc. ]
    • Lake Erie Medical Dba Quality Care Products Llc
      Metformin Hydrochloride Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
      Metformin Hydrochloride Tablet, Film Coated [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
    • Proficient Rx Lp
      Metformin Hydrochloride Tablet, Film Coated [Proficient Rx Lp]
    • Blenheim Pharmacal, Inc.
      Metformin Hydrochloride Tablet, Extended Release [Blenheim Pharmacal, Inc.]
    • Blenheim Pharmacal, Inc.
      Metformin Hydrochloride Tablet, Film Coated [Blenheim Pharmacal, Inc.]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
    • Blenheim Pharmacal, Inc.
      Metformin Hydrochloride Tablet [Blenheim Pharmacal, Inc.]
    • Blenheim Pharmacal, Inc.
      Metformin Hydrochloride Tablet [Blenheim Pharmacal, Inc.]
    • Blenheim Pharmacal, Inc.
      Metformin Hydrochloride Tablet [Blenheim Pharmacal, Inc.]
    • Direct Rx
      Metformin Hydrochloride Tablet [Direct Rx]
    • Northwind Pharmaceuticals
      Metformin Hydrochloride Tablet [Northwind Pharmaceuticals]
    • State Of Florida Doh Central Pharmacy
      Metformin Hydrochloride Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
    • Cardinal Health
      Metformin Hydrochloride Tablet [Cardinal Health]
    • Proficient Rx Lp
      Metformin Hydrochloride Tablet, Film Coated [Proficient Rx Lp]
    • American Health Packaging
      Metformin Hydrochloride Tablet, Extended Release [American Health Packaging]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
    • Avkare, Inc.
      Metformin Hydrochloride Tablet, Extended Release [Avkare, Inc.]
    • Tya Pharmaceuticals
      Metformin Hydrochloride Tablet [Tya Pharmaceuticals]
    • Solco Healthcare U.s., Llc
      Metformin Hydrochloride Tablet, Film Coated [Solco Healthcare U.s., Llc]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Provident Pharmaceutical, Inc
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet, Film Coated [Provident Pharmaceutical, Inc]
    • Alphapharm Pty Ltd
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet [Alphapharm Pty Ltd]
    • Dr. Reddy’s Laboratories Limited
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet, Film Coated [Dr. Reddy’s Laboratories Limited]
    • Caraco Pharmaceutical Laboratories, Ltd.
      Metformin Hydrochloride Tablet, Extended Release [Caraco Pharmaceutical Laboratories, Ltd.]
    • Usv Limited
      Metformin Hydrochloride Tablet [Usv Limited]
    • Actavis Elizabeth Llc
      Metformin Hydrochloride Tablet, Extended Release [Actavis Elizabeth Llc]
    • Cadila Healthcare Limited
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet, Film Coated Metformin Hydrochloride ( Metformin Hydrochloride ) Tablet, Film Coated [Cadila Healthcare Limited]
    • State Of Florida Doh Central Pharmacy
      Metformin Hydrochloride Tablet Metformin Hydrochloride (Metformin Hydrochloride ) Tablet [State Of Florida Doh Central Pharmacy]
    • Caraco Pharmaceutical Laboratories, Ltd
      Metformin Hydrochloride Tablet Metformin Hydrochloride Tablet Metformin Hydrochloride (Metformin Hydrochloride ) Tablet [Caraco Pharmaceutical Laboratories, Ltd]
    • Torrent Pharmaceuticals Limited
      Metformin Hydrochloride Tablet, Film Coated [Torrent Pharmaceuticals Limited]
    • Torrent Pharmaceuticals Limited
      Metformin Hydrochloride Tablet, Extended Release Metformin Hydrochloride Tablet, Extended Release [Torrent Pharmaceuticals Limited]
    • Physicians Total Care, Inc.
      Metformin Hydrochloride Tablet, Extended Release [Physicians Total Care, Inc.]
    • Contract Pharmacy Services-pa
      Metformin Hydrochloride Tablet, Film Coated [Contract Pharmacy Services-pa]
    • State Of Florida Doh Central Pharmacy
      Metformin Hydrochloride Tablet, Extended Release [State Of Florida Doh Central Pharmacy]
    • State Of Florida Doh Central Pharmacy
      Metformin Hydrochloride Tablet, Film Coated [State Of Florida Doh Central Pharmacy]
    • State Of Florida Doh Central Pharmacy
      Metformin Hydrochloride Tablet [State Of Florida Doh Central Pharmacy]
    • Aurobindo Pharma Limited
      Metformin Hydrochloride Tablet, Film Coated [Aurobindo Pharma Limited]
    • Glenmark Generics Inc., Usa
      Metformin Hydrochloride Tablet [Glenmark Generics Inc., Usa]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet, Film Coated [Remedyrepack Inc. ]
    • Zydus Pharmaceuticals (Usa) Inc.
      Metformin Hydrochloride Tablet, Film Coated [Zydus Pharmaceuticals (Usa) Inc.]
    • Remedyrepack Inc.
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet, Film Coated [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet [Remedyrepack Inc. ]
    • Cardinal Health
      Metformin Hydrochloride Tablet, Film Coated [Cardinal Health]
    • Cardinal Health
      Metformin Hydrochloride Tablet, Film Coated [Cardinal Health]
    • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
      Metformin Hydrochloride Tablet, Extended Release [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Qualitest Pharmaceuticals
      Metformin Hydrochloride Tablet, Film Coated [Qualitest Pharmaceuticals]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet, Extended Release [Remedyrepack Inc. ]
    • Rebel Distributors Corp.
      Metformin Hydrochloride Tablet [Rebel Distributors Corp.]
    • Lupin Pharmaceuticals Inc
      Metformin Hydrochloride Tablet, Extended Release [Lupin Pharmaceuticals Inc]
    • Unit Dose Services
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet [Unit Dose Services]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
    • Zydus Pharmaceuticals (Usa) Inc.
      Metformin Hydrochloride Tablet, Film Coated Metformin Hydrochloride Tablet, Extended Release [Zydus Pharmaceuticals (Usa) Inc.]
    • Cadila Healthcare Limited
      Metformin Hydrochloride Tablet, Film Coated Metformin Hydrochloride Tablet, Extended Release [Cadila Healthcare Limited]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Lake Erie Medical Dba Quality Care Products Llc
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Rebel Distributors Corp
      Metformin Hydrochloride Tablet, Extended Release [Rebel Distributors Corp]
    • Medvantx, Inc.
      Metformin Hydrochloride Tablet, Film Coated [Medvantx, Inc.]
    • Nostrum Laboratories Inc.
      Metformin Hydrochloride Tablet, Extended Release [Nostrum Laboratories Inc.]
    • Legacy Pharmaceutical Packaging
      Metformin Hydrochloride Tablet, Film Coated [Legacy Pharmaceutical Packaging]
    • Life Line Home Care Services, Inc.
      Metformin Hydrochloride Tablet [Life Line Home Care Services, Inc.]
    • Watson Laboratories, Inc.
      Metformin Hydrochloride Tablet, Film Coated, Extended Release [Watson Laboratories, Inc.]
    • Avpak
      Metformin Hydrochloride Tablet, Extended Release [Avpak]
    • Cardinal Health
      Metformin Hydrochloride Tablet [Cardinal Health]
    • Cardinal Health
      Metformin Hydrochloride Tablet, Film Coated [Cardinal Health]
    • Mckesson Contract Packaging
      Metformin Hydrochloride Tablet, Film Coated [Mckesson Contract Packaging]
    • Heritage Pharmaceuticals Inc.
      Metformin Hydrochloride Tablet [Heritage Pharmaceuticals Inc.]
    • Inventia Healthcare Private Limited
      Metformin Hydrochloride Tablet, Extended Release [Inventia Healthcare Private Limited]
    • American Health Packaging
      Metformin Hydrochloride Tablet [American Health Packaging]
    • Medvantx, Inc.
      Metformin Hydrochloride Tablet, Extended Release [Medvantx, Inc.]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Watson Pharma, Inc.
      Metformin Hydrochloride Tablet, Film Coated Metformin Hydrochloride Tablet, Extended Release [Watson Pharma, Inc.]
    • Aurobindo Pharma Limited
      Metformin Hydrochloride Tablet, Extended Release [Aurobindo Pharma Limited]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet, Extended Release [Pd-rx Pharmaceuticals, Inc.]
    • Teva Pharmaceuticals Usa Inc
      Metformin Hydrochloride Tablet, Extended Release [Teva Pharmaceuticals Usa Inc]
    • Amneal Pharmaceuticals
      Metformin Hydrochloride (Metformin) Tablet [Amneal Pharmaceuticals]
    • Amneal Pharmaceuticals
      Metformin Hydrochloride Tablet, Extended Release [Amneal Pharmaceuticals]
    • Physicians Total Care, Inc.
      Metformin Hydrochloride Tablet [Physicians Total Care, Inc.]
    • Mylan Pharmaceuticals Inc.
      Metformin Hydrochloride Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
    • Stat Rx Usa Llc
      Metformin Hydrochloride (Metformin Hydrochloride) Tablet, Film Coated [Stat Rx Usa Llc]
    • Major Pharmaceuticals
      Metformin Hydrochloride Tablet, Extended Release [Major Pharmaceuticals]
    • Bryant Ranch Prepack
      Metformin Hydrochloride Tablet, Extended Release [Bryant Ranch Prepack]
    • Aidarex Pharmaceuticals Llc
      Metformin Hydrochloride Tablet [Aidarex Pharmaceuticals Llc]
    • Aidarex Pharmaceuticals Llc
      Metformin Hydrochloride Tablet [Aidarex Pharmaceuticals Llc]
    • Major Pharmaceuticals
      Metformin Hydrochloride Tablet [Major Pharmaceuticals]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride (Metformin) Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet, Extended Release [Pd-rx Pharmaceuticals, Inc.]
    • Pd-rx Pharmaceuticals, Inc.
      Metformin Hydrochloride Tablet [Pd-rx Pharmaceuticals, Inc.]
    • Remedyrepack Inc.
      Metformin Hydrochloride Tablet [Remedyrepack Inc. ]
    • Major Pharmaceuticals
      Metformin Hydrochloride Tablet, Film Coated [Major Pharmaceuticals]