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Posted On: Nov 20, 2019
Suspending the use of Medicines Containing Ranitidine as an Active Pharmaceutical Ingredient

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PRESS RELEASE

18th November, 2019

SUSPENDING THE USE OF MEDICINES CONTAINING RANITIDINE AS AN ACTIVE PHARMACEUTICAL INGREDIENT

  1. The Tanzania Medicines and Medical Devices Authority (TMDA) has conducted a comprehensive review of all human medicines containing ranitidine as an active pharmaceutical ingredient (API).
  2. Ranitidine is a medicine used for multiple indications to include treatment and prevention of ulcers of the stomach and intestines, controlling gastric acid production in heartburn as well as treatment of gastro-esophageal reflux disease (GERD).
  3. Review of products containing ranitidine focused on identifying those that contain N-nitrosodimethylamine (NDMA) – an impurity that has recently been proved to be potentially carcinogenic (i.e. can cause cancer to human beings).
  4. Following the review, medicinal products listed below have been observed to generate the concerned impurity during production:-
    S/N. Trade name Generic Name and Strength Marketing Authorization Holder (Registrant) Dosage Form
    1. Raniplex 150 mg Ranitidine Hydrochloride 150 mg Remedica Limited, Cyprus Tablets
    2. Rantac 500 mg/mL Ranitidine Hydrochloride 500 mg/2 mL Unique Pharmaceutical Laboratories ( A Division of J.B. Chemicals & Pharmaceuticals Ltd), India. Solution for Injection
    3. Aciloc 150 mg Ranitidine Hydrochloride Ranitidine 150 mg Cadila Pharmaceuticals Limited, India Tablets
  5. In connection to this and in order to protect public health, TMDA has suspended the use of these medicinal products with effect from 15th November 2019.
  6. All manufacturers have been informed and instructed to change their formulations including manufacturing processes to produce products that do not generate the impurity.
  7. As there are alternative products for similar indications such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole which have been approved for use by TMDA, patients are advised to consult their healthcare providers to obtain new prescriptions depending on their disease conditions.
  8. All wholesalers and retailers are further directed to stop distributing or selling the above-mentioned products respectively and notify TMDA for guidance on recall and disposal of the same.
  9. It should be noted that the suspension is only for the three products listed above and that other products containing ranitidine and manufactured by other manufactures have not been suspended and they can be used.
  10. Nevertheless, users are still reminded to notify TMDA of any adverse drug reactions (ADRs) that might occur as a result of use of these medicines or any other medicines as part of its pharmacovigilance system.
  11. It should also be noted that the suspension, ban and recall of ranitidine products containing the impurity N-nitrosodimethylamine is currently underway in many other countries globally.
Issued by:
Acting Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
Mwanza Street, Block T, Plot No.6,
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phone: +255 22 2452108/2450512/2450751
Fax: +255 22 2450793
Hotline: 0800110084