TGA releases list of Ranitidine products impacted by recall
Ranitidine tablets and oral liquids are now in short supply as a number of commonly-used brands have been recalled from pharmacies, hospitals, wholesalers, and other retail outlets, such as supermarkets and online stores, the TGA has warned.
In an updated version of an alert initially issued late last week, The TGA is advising consumers and health professionals that “several ranitidine-containing products have been removed from the Australian market due to contamination with an impurity called N‑nitrosodimethylamine (NDMA).
Additional brands may be recalled as TGA continues testing and discussions with companies that supply ranitidine,” the agency says.
Retail level recalls relating to this issue are currently being undertaken for various strengths, pack sizes and dosage forms for a range of Ranitidine products. These are:
- Sandoz ranitidine (marketed under the brand names “Sandoz Ranitidine” and “Mylanta Ranitidine”)
- Aspen ranitidine (marketed under the brand name “Zantac”)
- Alphapharm ranitidine (marketed under the brand name “RANI 2”)
- Apotex ranitidine (marketed under the brand names “APO”, “CHEMMART”, “TERRY WHITE CHEMISTS” and “APOHEALTH”)
- Symbion ranitidine (marketed under the brand names “Pharmacy Choice Acid and Heartburn Relief” / “Extra Strength”)
- Cipla Australia ranitidine (marketed under the brand names “AMCAL” and “Pharmacy Care”)
- Generic Health ranitidine (marketed under the brand name “Pharmacy Action”).
- Nova Pharmaceuticals Australasia ranitidine (marketed under the brand names “Coles (and) Medix Heartburn & Acid Indigestion”).
- Australian Pharmaceutical Industries Ltd t/a Soul Pattinson Manufacturing ranitidine (marketed under the brand names “Pharmacy Health (and) Priceline Pharmacy Reflux Relief Extra Strength Ranitidine” and “Terrywhite Chemmart Heartburn Relief Extra Strength Ranitidine”)
- Arrow Pharma ranitidine (marketed under the brand names “AUSRAN Ranitidine”, “CHEMIST’S OWN RANITIDINE FORTE” and “CHEMIST’S OWN RANITIDINE”).
While all batches of the first nine products are being recalled, following testing, only some batches of Arrow Pharma ranitidine are being recalled, the TGA has advised.
It is advising people to refer to the System for Australian Recall Actions (SARA) database for specific, affected batch numbers and expiry dates.
Health professionals are advised to reassure patients that the additional risk posed by NDMA from ranitidine at the levels identified to date is very low. However, for patients who are currently taking ranitidine these risks may outweigh the clinical benefits.
Pharmacists who are providing advice to patients accessing ranitidine over the counter should discuss treatment options and review whether ongoing pharmacotherapy is appropriate, the TGA says.