Tetanus And Diphtheria Toxoids Adsorbed Recall
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Questions & Answers
Side Effects & Adverse Reactions
FREQUENCY OF ADMINISTRATION
More frequent administration of MassBiologics' Td than described in DOSAGE AND ADMINISTRATION may be associated with an increased incidence and severity of adverse reactions.
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive MassBiologics' Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management. (See DOSAGE AND ADMINISTRATION).
A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré Syndrome.9 If Guillain-Barré Syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of MassBiologics' Td or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.10
Vaccination with MassBiologics' Td may not protect all individuals.
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FDA Safety Alerts
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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.
MassBiologics' Td is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.
There is currently no drug history available for this drug.
Tetanus and Diphtheria Toxoids Adsorbed (Td) manufactured by MassBiologics is a sterile vaccine for intramuscular injection. After shaking, the vaccine appears as a homogeneous milky white suspension.
Each 0.5 ml dose of MassBiologics' Td is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Each 0.5 ml dose also contains aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde, and a trace amount of thimerosal [mercury derivative, (≤ 0.3 mcg mercury/dose)] (not as a preservative) from the manufacturing process.
The Corynebacterium diphtheriae and Clostridium tetani organisms are grown on modified Mueller's media1,2 which contains bovine extracts. The bovine material used in these extracts is sourced from countries which the United States Department of Agriculture has determined neither have nor present an undue risk for bovine spongiform encephalopathy. Tetanus and diphtheria toxins produced during growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by ammonium sulfate fractionation. The diphtheria toxoid is further purified by column chromatography. The tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.
The tetanus and diphtheria toxoids induce at least 2 units and 1 unit of antitoxin per ml of serum, respectively, in the guinea pig potency test.