Theracys 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

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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.


TheraCys is indicated for intravesical use in the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR).

Limitation of Use: TheraCys is not recommended for

  • Stage Ta low-grade papillary tumors, unless they are judged to be at high risk of recurrence.
  • Immunization against tuberculosis.


There is currently no drug history available for this drug.

Other Information

TheraCys, BCG Live (Intravesical) is a freeze-dried preparation made from the Connaught strain of Bacillus Calmette and Guérin, which is an attenuated strain of Mycobacterium bovis.

The BCG organisms in the product are grown on media containing potatoes, glycerine, asparagine, citric acid, potassium phosphate, magnesium sulfate, ferric ammonium citrate, calcium chloride, copper sulfate, and zinc sulfate. Monosodium glutamate is added to the BCG organisms prior to freeze-drying.

Each vial of TheraCys contains 81 mg of freeze-dried BCG. The freeze-dried BCG does not contain any preservative.

One dose of TheraCys consists of one 81mg vial of freeze-dried BCG reconstituted and diluted in 50 mL sterile, preservative-free saline.

The BCG organisms from the vial are viable. In vitro potency is determined by an assay of live BCG organisms based on the number of colonies observed when grown on solid medium. The reconstituted product contains 10.5 ± 8.7 × 108 colony-forming units (CFU) per vial.

Theracys Manufacturers

  • Sanofi Pasteur Inc.
    Theracys (Bacillus Calmette-guerin Substrain Connaught Live Antigen) Injection, Powder, Lyophilized, For Solution [Sanofi Pasteur Inc.]

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