Oct
23
2013

Specialty Medicine Compounding Pharmacy and the FDA are warning veterinarians and physicians in Michigan about the risk of contamination in certain injectable drugs that were distributed within the state.

According to a recall notice posted on the FDA website, the Michigan-based compounding pharmacy is voluntarily recalling all lots of unexpired compounded veterinary and human sterile products. The recall comes after the discovery of unidentified particulate matter in vials of a compounded dextrose injection product administered to patients at a Michigan hospital.

Affected products were distributed to medical facilities and patients in Michigan between July 1, 2013, and Oct. 19, 2013.

Specialty Medicine Compounding Pharmacy emphasized that it has not been made aware of any adverse events tied to the recall, and that the products were not distributed outside of Michigan.  

The compounding pharmacy shared a list of recalled products, which include:

  • Amikacin Sulfate, 250mg/ml
  • Buprenorphine HCL, 0.3mg/ml
  • Buprenorphine HCL, 0.6mg/ml
  • Ceftazidime in pluronic 250mg/ml gel
  • Cyclosporin A Oint, 0.2% (ophthalmic)
  • Cyclosporin MCT, 0.2% (ophthalmic)
  • Cyclosporin MCT, 1% (ophthalmic)
  • Desmopressin Acetate (0.01%), 0.1mg/ml
  • Desmopressin Acetate (0.0125%), 0.125mg/ml
  • Desmopressin Acetate (0.02%), 0.2mg/ml
  • Diclofenac Sodium Oint, 0.1% (ophthalmic)
  • Idoxuridine Ophthalmic, 0.1%
  • Phenobarbital Sodium, 65mg/ml
  • Prednisone, 10mg/ml
  • Tacrolimus, 0.02% (ophthalmic drops)
  • Tacrolimus, 0.03% (ophthalmic drops)
  • Tacrolimus Ointment, 0.03% (ophthalmic)
  • Ticarcillin in Pluronic, 250mg/ml gel
  • Xylazine 100mg/ml

 

Instructions for handling recalled products

The compounding pharmacy recommended that anyone in possession of recalled products immediately discontinue use, quarantine all sterile products, and contact the pharmacy at 248-446-2643 to arrange for return. 

The pharmacy also encouraged people to report adverse reactions to the FDA’s MedWatch program via:

  • Online: www.fda.gov/medwatch/report.htm1
  • Mail: Use postage-paid, pre-addressed Form FDA 3500 at www.fda.gov/MedWatch/getforms.htm2
  • Fax: 1-800-FDA-0178
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