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
City:Lewis Center
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

Ibandronate Sodium

Ibandronate Sodium

Ibandronate Sodium Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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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.


1.1       Treatment and Prevention of Postmenopausal Osteoporosis

Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

1.2 Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.


There is currently no drug history available for this drug.

Other Information

Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone  resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1diphosphonic acid, monosodium salt, with the molecular formula C9H22NO7P2Na and a molecular weight of 341. Ibandronate sodium is an off-white to white colored powder. It is sparingly soluble in water. Ibandronate sodium has the following structural formula:


Ibandronate sodium tablets are available as a white, capsule shaped 150-mg coated tablets for once-monthly oral administration. One 150 mg coated tablet contains 160.33 mg ibandronate sodium, equivalent to 150 mg of ibandronic acid. Ibandronate sodium tablets also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The tablet coating contains hypromellose, polyethylene glycol 400, and titanium dioxide. Imprinting ink contains: ammonium hydroxide, black iron oxide, propylene glycol and shellac.

Ibandronate Sodium Manufacturers

  • Dr. Reddy’s Laboratories Limited
    Ibandronate Sodium Tablet [Dr. Reddy’s Laboratories Limited]
  • Watson Laboratories, Inc.
    Ibandronate Sodium Tablet [Watson Laboratories, Inc.]
  • Apotex Corp
    Ibandronate Sodium Tablet, Film Coated [Apotex Corp]
  • Avkare, Inc.
    Ibandronate Sodium (Ibandronate Sodium) Tablet [Avkare, Inc.]
  • Sun Pharmaceutical Industries Limited
    Ibandronate Sodium Injection, Solution [Sun Pharmaceutical Industries Limited ]
  • Mylan Pharmaceuticals Inc.
    Ibandronate Sodium Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Alvogen Inc.
    Ibandronate Sodium Tablet [Alvogen Inc.]
  • Sagent Pharmaceuticals
    Ibandronate Sodium Injection, Solution [Sagent Pharmaceuticals]
  • Mylan Institutional Llc
    Ibandronate Sodium Injection, Solution [Mylan Institutional Llc ]
  • Heritage Pharmaceuticals Inc.
    Ibandronate Sodium Injection, Solution [Heritage Pharmaceuticals Inc.]

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