Merck Sharp & Dohme Recalls Six Batches of Zerbaxa Due to Potential Microbial Contamination

Recently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued two drug recall notices:

MSD Recalls Its Combination Antibiotic Product Zerbaxa Due to Microbial Contamination Across Multiple Batches; Fresenius Kabi Recalls 0.9% Sodium Chloride Injection Due to Polish-Language Labels on Certain Ampoules

MSD Recall: Sterile Products at Risk of Microbial Contamination

Merck Sharp & Dohme Limited Recalls Its Combination Antibiotic Product Zerbaxa. This recall involves specific batches of Zerbaxa powder for concentrate for solution for infusion, with a strength of 1 g/0.5 g.

Figure: Recalled product: the combination antibiotic Zerbaxa. Active ingredients: ceftolozane sulfate/tazobactam sodium.

Question

The reason for MSD’s recall of the aforementioned batches is the detection of Ralstonia pickettii contamination in recently produced batches. In light of this deviation, MSD has initiated a further investigation into the microbial quality of distributed products. As a precautionary measure, MSD has decided to recall the following commercially available batches:

Figure: List of Recalled Product Batches

MSD stated that the likelihood of contamination in the aforementioned batches is very low. Even if Ralstonia pickettii were present in these batches, the level of contamination would be unlikely to cause serious adverse health consequences.

Ralstonia pickettii is a Gram-negative bacterium found in soil, rivers, and lakes. In water systems containing industrial plastics, it can occur as biofilm-forming bacteria.

Advice for Healthcare Professionals

Immediately halt the supply of the above batches. Quarantine all inventory and return it to the supplier using supplier-approved procedures.

If patients experience worsening symptoms or other suspected adverse effects during treatment with Zerbaxa, these should be reported via the Yellow Card Scheme (the UK’s adverse reaction reporting system).

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Fresenius Kabi: Label Language Error

Fresenius Kabi Ltd is recalling 0.9% Sodium Chloride Injection. Although the ampoule labels in some cartons are in Polish, which does not affect the entire batch, Fresenius Kabi has decided to recall all packages of this batch as a precautionary measure.

Figure: Warning Notice from the UK Medicines Regulator

Question

Fresenius Kabi stated that the cartons for this batch were correct and included the appropriate package leaflet (English version). The drug substance and specifications complied with the requirements for the UK marketing authorization; however, some ampoule labels from an incorrect version were used during the production of this batch.

Fresenius Kabi has decided to recall the affected batches listed below; all returned products will be replaced with other inventory batches.

Figure: Batch Information of Recalled Products