B Braun Melsungen AG has changed the type of stoppers used to seal its injectable metabolic acidosis treatment, sodium bicarbonate, after quality problems that resulted in a UK MHRA alert last week.
The drug alert – which was issued on December 5 – covers 100ml and 250ml packs of sodium bicarbonate belonging to batch numbers 120428021 to 131558022 that were produced last year.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) said it issued the warning after B Braun detected aluminium salt precipitation during routine inspection of sample vials.
Subsequent investigation suggested that fluctuations in the quality of the bromobutyl stoppers used to seal bottles belongong to the affected batches resulted in the leaching of aluminium compounds.
The Germany-based pharmaceutical firm confirmed the alert and told in-Pharmatechnologist.com that: “Production has been switched to a new suitable stopper material” but did not provide additional details of the replacement it has chosen.
The drug alert – which was a precautionary measure targeted at the hospitals and wholesalers which buy the product from B Braun – recommends that doctors check that vials are free of particles and employ a 15micron filter before use.
Sodium bicarbonate - chemical formula NaHCO3 - is used in a wide variety of industries including food production where "baking soda" is used to expand the batter used to produce pancakes, cakes, quick breads, soda bread, and other baked and fried foods, giving them their characteristic texture and form.
In medicine, sodium bicarbonate is used to reduce acid levels in a wide variety of conditions ranging from metabolic acidosis to barbiturate intoxication. It is also used to improve the solubility of insoluble APIs.
The MHRA did not order a recall “due to concerns with continuity of supply.” This was acknowledged by B Braun, which told us that it “is one of the main suppliers” of medical grade sodium bicarbonate. Other major medical sodium bicarbonate suppliers include Solvay and FMC.