NDA recalls 14 drugs over quality defects

The National Drug Authority (NDA) has recalled various frequently consumed drugs over quality queries, barely a month after the national drug regulator withdrew substandard condoms from the market.

This has triggered public fear about the health implications to the people who consumed them.
The NDA has ordered the recall of 14 brands of drugs manufactured by a Chinese company for failure to meet quality standards.

The recalled drugs, mostly injectable antibiotics, include painkillers and other medicines used for controlling postpartum haemorrhage (excessive bleeding after child delivery), and those used during surgical procedures.

The directive
“We have been instructed by NDA to recall the below-listed drugs manufactured by Zhejiang Pharmaceuticals Company Limited due to GMP [Good Manufacturing Processing] failure,” Astra Pharma (U) Limited, one of the distributors, wrote to pharmacy customers on December 5.

The drugs comprise Gentamycin injection 80mg/ml, Oxytocin injection 10 IU/ml, Diclofenac Injection 25mg/ml, and Chloramphenicol 250mg Capsules
Other drugs are; Quinine Injection 300mg/ml, Tetracycline 250mg capsules, Lidocaine injection 20mg/ml, Lidocaine injection 20mg/ml, Aminophylline 25mg/ml, Atropine injection mg/ml, Metoclopramide injection mg/ml, Chlorpromazine 25mg/ml, Vitamin B complex injection, Indomethacin 25mg capsules and Promethazine Injection 25mg.

“Kindly return all unsold quantity to us immediately (in any case not less than seven days from receipt of the letter) and a credit note will be issued to you. Please contact the customers to which you sold any of the above, and ask them to return it to you and in turn bring it to us. Kindly treat this matter with utmost importance,” the letter of Astra Pharma further reads. It is signed by pharmacist Francis Otim E.

Yesterday, one of the employees at Astra Pharma (U) Limited, who declined to be named, acknowledged that the letter was authored by the company but refused to delve into the details and asked us to call again today when the pharmacist is available.

Dr David Nahamya, the NDA secretary, confirmed they have recalled the drugs but was hesitant to give further details about the quantity. He only said it is a normal procedure that is done to ensure quality control.
“It is a normal thing in regulation. There is nothing new. It is the reason we are there,” Dr Nahamya told Daily Monitor by telephone yesterday.

Asked if the numerous previous withdrawals of drugs and condoms on the market does not undermine NDA’s credibility on competence, Dr Nahamya said: “You should be applauding us. That is our daily bread.”

Mr Samuel Opio, the president of Uganda Pharmaceutical Society, said in such circumstances where quality has to be corrected, there needs to be an evaluation on whether the users would have been affected and guided to take certain precautions.

“You may not go to everyone but you may issue out certain precautions,” Mr Opio said.
Last month NDA directed Marie Stopes Uganda, an NGO that offers reproductive health services, to recall two batches of Life Guard brand condoms from the market following customers’ complaints about quality.

Recalled drugs and what they treat

• Gentamycin injection 80mg/ml. It prevents or treats a wide variety of bacterial infections. Oxytocin injection 101.U/ml. It activates uterus contractions to induce labour during child delivery and strengthens labor contractions, controls bleeding after childbirth or to induce an abortion
• Diclofenac Injection 25mg/ml
  a Non-steroidal anti-inflammatory (NSAID) drug used to treat pain associated with conditions like Gout, Migraine, Rheumatoid Arthritis, sprains of muscles and joints and in mild to moderate fever in some cases
• Chloramphenicol 250mg Capsules. It treats of serious infections caused by bacteria where other medicines have been ineffective
• Quinine Injection 300mg/ml.
  It is administered parenterally to patients with severe or complicated malaria who cannot take drugs by mouth because of coma, convulsions or vomiting.
• Tetracycline 250mg capsules.
  Used to treat a wide variety of infections, including acne.
• Lidocaine injection 20mg/ml.
  Reduce sensation or pain by blocking nerve impulses that cause pains.
• Aminophylline 25mg/ml.
  Indicated for relief of bronchospasm associated with asthma and in chronic obstructive pulmonary disease.
• Atropine injection mg/ml.
  As a preoperative medication for the reduction of salivary and bronchial secretions.
• Metoclopramide injection mg/ml. Prevents nausea and vomiting from surgery or chemotherapy.
• Chlorpromazine 25mg/ml
  Chlorpromazine is also used to control nausea/vomiting.
• Vitamin B complex injection
  Provides the water-soluble vitamins which are essential to carbohydrate and fat metabolism.
• Indomethacin 25mg capsules
  Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis.
  Promethazine Injection 25mg
  Used to prevent or treat nausea and vomiting.
  

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