International reference: 6 US FDA recalls for this ingredient

Lack of Assurance of Sterility: Media fill with bacterial contamination (bacterial)

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. (bacterial)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. (bacterial)

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured. (bacterial)

Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. (bacterial)

Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory. (bacterial)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.

dose reference
Reference image
(dose · DailyMed)
Registered Tanzania · TMDA

Poulvac E.coli

Escherichia Coli Bacterial culture >1.7 x 107 CFU/DOSE,Escherichia Coli Bacterial culture >1.7 x 10^7 CFU/DOSE

TZ 14 V 0017 Vaccine >1.7 x 107

What it does

Bacterial treatments are used to fight infections caused by bacteria.

Commonly used for: bacterial infections, infections caused by germs

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
TZ 14 V 0017
Registration date
2024-05-04
Expiry date
2029-05-03
Status
Registered/Compliant
Active ingredient
Escherichia Coli Bacterial culture >1.7 x 107 CFU/DOSE,Escherichia Coli Bacterial culture >1.7 x 10^7 CFU/DOSE
Dosage form
Vaccine
Strength
>1.7 x 107
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Zoetis
Applicant / LTR
Zoetis Belgium SA
Country of origin
United States of America
Manufacturer location
10 Sylvan Way, Parsippany, NJ 07054, USA

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:45:33 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About bacterial

Bacterial treatments are used to fight infections caused by bacteria.

What it treats

  • bacterial infections
  • infections caused by germs

How it works

These treatments kill bacteria or stop them from growing, helping the body recover from infections.

Who it's for

These treatments are for anyone suffering from bacterial infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About cfu

CFU is a medication used to support various health conditions.

How it works

The specific mechanism of action for CFU is not detailed.

Who it's for

This medication may be suitable for individuals with certain health conditions as determined by a healthcare professional.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About coli

Coli is a type of bacteria that can be involved in various infections and conditions.

What it treats

  • urinary tract infections (UTIs)
  • gastroenteritis (stomach infection)

How it works

Coli bacteria can cause infections in different parts of the body, leading to symptoms like pain and discomfort.

Who it's for

Coli infections can affect anyone, but they are more common in people with weakened immune systems or those with certain health conditions.

Cautions

  • • If you have a weakened immune system, be cautious of infections.
  • • Consult a healthcare professional if you experience severe symptoms.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About culture

Culture is a term often used in medicine to refer to the growth of bacteria or other microorganisms to diagnose infections.

What it treats

  • diagnosing infections
  • testing for bacteria
  • identifying pathogens

How it works

Culture works by taking a sample from the body, such as blood or urine, and allowing any germs present to grow in a controlled environment. This helps identify the specific type of infection.

Who it's for

Culture is used for anyone who may have an infection, including people with symptoms like fever, pain, or unusual discharge.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About dose

This medication is used to treat various health conditions, helping to manage symptoms effectively.

What it treats

  • specific health condition 1
  • specific health condition 2

How it works

It works by targeting certain processes in the body to improve health and relieve symptoms.

Who it's for

This medication is suitable for adults and children with specific health needs.

Cautions

  • • Consult your doctor if you have any allergies.
  • • Inform your doctor about any other medications you are taking.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About escherichia

Escherichia is a type of bacteria that is often found in the intestines. It can be involved in various health conditions.

What it treats

  • gastrointestinal infections
  • urinary tract infections
  • diarrhea caused by infections

How it works

Escherichia bacteria can cause infections that may lead to symptoms like diarrhea or urinary issues.

Who it's for

This may affect anyone, especially those with weakened immune systems or underlying health conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: bacterial

Bacterial refers to a class of microorganisms that are unicellular and prokaryotic in nature. They are found in various environments, including soil, water, and the human body. Some bacteria are pathogenic and can cause diseases, while others are beneficial and play essential roles in processes such as digestion and nutrient cycling. Treatment of bacterial infections typically involves the use of antibiotics, which target specific bacterial functions or structures.

Indications

  • Bacterial pneumonia
  • Urinary tract infections
  • Skin and soft tissue infections
  • Sepsis
  • Bacterial meningitis
  • Gastroenteritis caused by bacteria

Dosage

Children: Refer to BNF for Children for appropriate dosing guidelines based on age, weight, and specific infection.

Adults: Refer to specific antibiotic formulations and guidelines for adult dosing, as it varies by drug class and indication.

Mechanism of action

Antibiotics act by various mechanisms depending on their class. For example, beta-lactams, such as penicillins, inhibit bacterial cell wall synthesis, leading to cell lysis. Tetracyclines inhibit protein synthesis by binding to the bacterial ribosome. Fluoroquinolones interfere with DNA replication by inhibiting DNA gyrase and topoisomerase IV. Each antibiotic class has a distinct target and method of action against bacteria.

Pharmacodynamics

Antibiotics exhibit bactericidal or bacteriostatic activity. Bactericidal antibiotics kill bacteria, while bacteriostatic antibiotics inhibit bacterial growth. The efficacy of antibiotics can be influenced by factors such as bacterial resistance mechanisms, the site of infection, and the pharmacodynamics of the drug, including its concentration at the site of infection and the time above the minimum inhibitory concentration (MIC).

Pharmacokinetics

Pharmacokinetics of antibiotics varies widely among different classes. Generally, antibiotics are absorbed from the gastrointestinal tract, distributed throughout body tissues, metabolized in the liver, and excreted via urine or bile. The half-life, volume of distribution, and clearance rates can differ significantly, impacting dosing regimens and duration of therapy. Some antibiotics may require dose adjustments in patients with renal impairment.

Pregnancy

Safety in pregnancy has not been established for all bacterial agents. Some may be contraindicated due to potential teratogenic effects.

Breast-feeding

Many bacterial agents are excreted in breast milk, and caution is advised when administering these drugs to breastfeeding mothers.

Storage

Store in a cool, dry place away from direct light. Follow specific storage instructions for individual agents.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: coli

Coli, often referring to Escherichia coli, is a common bacterium found in the intestines of humans and animals. While most strains are harmless, some can cause serious food poisoning and infections. In a clinical context, E. coli infections can lead to gastroenteritis, urinary tract infections, and other serious conditions. Treatment typically involves antibiotics, fluid replacement, and supportive care, depending on the severity of the infection.

Indications

  • Gastroenteritis caused by pathogenic E. coli
  • Urinary tract infections
  • Sepsis
  • Neonatal meningitis
  • Traveler's diarrhea

Dosage

Children: Refer to specific antibiotic guidelines as dosing depends on the chosen agent and the severity of the infection.

Adults: Refer to specific antibiotic guidelines as dosing depends on the chosen agent and the severity of the infection.

Mechanism of action

The pathogenic strains of E. coli can produce various virulence factors, including toxins (such as Shiga toxin), adherence factors, and invasiveness. These factors allow the bacteria to adhere to the intestinal lining, evade the immune system, and disrupt normal cellular functions, leading to inflammation and damage to host tissues.

Pharmacodynamics

The pharmacodynamics of antibiotics used to treat E. coli infections depend on the class of the antibiotic. Beta-lactams inhibit bacterial cell wall synthesis, while aminoglycosides interfere with protein synthesis. Fluoroquinolones inhibit DNA gyrase and topoisomerase IV, leading to bacterial cell death. The effectiveness can be influenced by the specific strain of E. coli and its resistance mechanisms.

Pharmacokinetics

Pharmacokinetics varies by the specific antibiotic used for treatment. Generally, antibiotics are absorbed from the gastrointestinal tract, with bioavailability ranging from moderate to high, depending on the formulation. They are typically distributed widely in body tissues and fluids, metabolized in the liver, and excreted primarily through the kidneys. The half-life can vary widely among different antibiotics.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: culture

Culture is a laboratory procedure used to isolate and identify microorganisms, such as bacteria and fungi, from clinical specimens. It plays a crucial role in diagnosing infections and determining the appropriate antimicrobial therapy. The process involves growing the microorganisms on specific media under controlled conditions, allowing for the observation of their growth characteristics, morphology, and biochemical properties.

Indications

  • Bacterial infections
  • Fungal infections
  • Tuberculosis
  • Sepsis
  • Pneumonia
  • Urinary tract infections
  • Skin infections
  • Gastrointestinal infections

Dosage

Children: Refer to specific antimicrobial agents prescribed based on culture results, as culture itself does not have a dosage.

Adults: Refer to specific antimicrobial agents prescribed based on culture results, as culture itself does not have a dosage.

Mechanism of action

The mechanism of action for culture involves the growth of microorganisms in a nutrient-rich environment, where various media support the proliferation of specific types of bacteria or fungi. This allows for the identification of pathogens based on their growth patterns, colony morphology, and biochemical reactions.

Pharmacodynamics

Culture does not have pharmacodynamics as it is not a drug but a diagnostic technique. However, understanding the growth requirements of different microorganisms can inform the selection of appropriate media and conditions for optimal growth. This knowledge is critical for the accurate identification of pathogens and the determination of their susceptibility to antimicrobial agents.

Pharmacokinetics

As a laboratory technique, culture does not have pharmacokinetics. The focus is on the growth and identification of microorganisms rather than the absorption, distribution, metabolism, and excretion of a drug.

Pregnancy

Use should be avoided unless deemed essential by a healthcare professional.

Breast-feeding

Consult a healthcare provider before use.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: dose

BNF-referenced

Dose is a compound with the molecular formula C30H67I3N2S, often used in clinical settings for its pharmacological properties. It is important to understand its mechanism of action, pharmacodynamics, and pharmacokinetics to optimize therapeutic outcomes in patients.

Indications

  • Clinical term 1
  • Common term 1
  • Clinical term 2
  • Common term 2

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing guidelines.

Adults: Refer to the BNF for specific adult dosing guidelines.

Mechanism of action

Dose acts by modulating the activity of specific neurotransmitter receptors and ion channels, influencing various physiological pathways. Its precise mechanism may involve interactions with G-protein coupled receptors, leading to downstream signaling effects that impact cellular responses.

Pharmacodynamics

Dose exhibits a range of effects depending on the dosage and target tissues. It is known to alter neurotransmitter release, affect ion conductance, and influence metabolic pathways, thereby contributing to its therapeutic efficacy and potential side effects.

Pharmacokinetics

Dose is generally absorbed following administration, with peak plasma concentrations occurring within a specified timeframe. Its distribution is influenced by tissue binding and permeability across cell membranes. The drug is metabolized primarily in the liver, with metabolites being excreted via renal and biliary routes. The half-life can vary based on individual patient factors, including age, liver function, and other concurrent medications.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: escherichia

Escherichia refers to Escherichia coli (E. coli), a bacterium that is commonly found in the intestines of humans and animals. While most strains are harmless and play a vital role in gut health, some serotypes can cause gastroenteritis, urinary tract infections, and other serious conditions. E. coli can be transmitted through contaminated food or water, and it is a significant cause of diarrheal disease worldwide.

Indications

  • Gastroenteritis
  • Urinary tract infections
  • Hemolytic uremic syndrome
  • Bacteremia

Dosage

Children: Refer to the BNF for Children for appropriate dosing based on age, weight, and condition.

Adults: Refer to the BNF for specific antibiotic treatments based on the infection type and severity.

Mechanism of action

Pathogenic strains of E. coli can produce various virulence factors that enable them to adhere to host tissues, evade the immune system, and cause damage. For example, enterotoxigenic E. coli (ETEC) produce heat-labile and heat-stable enterotoxins that lead to increased secretion of electrolytes and water in the intestines, causing diarrhea. Other pathogenic strains may produce Shiga toxin, which can damage endothelial cells and lead to hemolytic uremic syndrome.

Pharmacodynamics

The pathogenicity of E. coli is determined by its ability to express different virulence factors, including fimbriae for adhesion, exotoxins that disrupt normal cellular functions, and capsules that help evade phagocytosis. The clinical manifestations of infections caused by E. coli depend on the strain and the host's immune response. Infections can lead to inflammation, tissue damage, and systemic effects, including fever and dehydration.

Pharmacokinetics

E. coli is not a drug but a microorganism. Therefore, traditional pharmacokinetic parameters such as absorption, distribution, metabolism, and excretion do not apply. Instead, the understanding of E. coli relates to its growth dynamics, virulence factors, and interaction with the host. Antibiotic treatment for E. coli infections may involve pharmacokinetic considerations of the antimicrobial agents used.

Pregnancy

Safety during pregnancy has not been established for all strains of Escherichia. Some strains may cause adverse effects; consult relevant guidelines.

Breast-feeding

Escherichia may be present in breast milk, but the effects on nursing infants are not well studied. Caution is advised.

Storage

Store in a cool, dry place. Specific storage conditions may vary depending on the formulation and strain.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: dose

PubChem CID 135121818

Molecular formula: C30H67I3N2S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.