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Recently, the MHRA, the UK's drug regulator, issued two drug recall notices: Mercadon recalled its compound antibiotic product Zerbaxa for microbial contamination, involving multiple batches, and Fessenyuscabi recalled 0.9% sodium chloride injections because some products were labeled Polish.
Recall: Merck Sharp and Dohme Limited, a sterile drug at risk of microbial contamination, recalls its compound antibiotic product, Zerbaxa.
recall involves specific batches of Zerbaxa infusion concentrate powders in sizes of 1g / 0.5g.
: Recalled product: compound antibiotic Zerbaxa.
the most active ingredient is ceftolozane sulfate / tazobactam sodium, the active ingredient in the recent production was recalled because of the presence of Ralstonia pickettii contamination in recently produced batches.
this deviation, Mercedon initiates further investigations into the microbial quality of distributed products.
as a precautionary measure, Mercadon decided to recall the following commercially available batches: Figure: Recalled Product Batch List Mercedon said the likelihood of contamination occurring in those batches was low.
even if these batches were present, the level of contamination would not be high and could lead to serious adverse health consequences.
is a Gloran-negative bacteria found in soil, rivers and lakes.
in water systems containing industrial plastics, they can be found in the form of biofilm bacteria.
to medical professionals to immediately stop supplying the above batches.
all inventory and return it to the supplier using a supplier-approved process.
patients with worsening symptoms or other suspicious side effects during treatment with Zerbaxa should be reported through the Yellow Card Program (UK Adverse Reaction Reporting System).
, Fessenyuskabi: Labeling language error Fresenius Kabi Ltd is recalling 0.9 percent sodium chloride injections.
the ampoules in some small boxes are labeled Polish, and while this will not affect the entire batch, Fessenyuscabi decided to recall all packages in this batch as a precaution.
: The UK's drug regulator's warning notice, Fessen Yuscabi, says the small box in the batch is correct and has the correct instructions (in English).
drug ingredients and specifications meet UK licensing requirements, the batch used the wrong version of the ampoule label in the production process.
Faison Yuscabi decided to recall the following batches affected, and all returns will be replaced with other inventory batches.
image: Recall product batch information