Novartis issued an urgent recall for medicines taken to combat Thrombocytopenia and Aplastic Anemiacalled Promacta (eltrombopag)because of possible peanut flour contamination. Novartis voluntarily recalled three lots of the drug. The peanut flour contamination happened at the manufacturing plant of a Novartis’ vendor and not at one of its plants. According to the report published in Pharmacy Times, Novartis is unaware of any illnesses or injuries stemming from the known food allergen.
Novartis decided to issue this recall due to the potential harm a peanut contamination could cause if anyone with a peanut sensitivity ingested a contaminated pill. A person with a peanut allergy who comes in contact with any amount of peanut could be stricken by anaphylactic shock. Anaphylaxis may be fatal if not treated immediately. Even trace amounts of peanut can incapacitate and kill a person with a peanut allergy.
The three lots of Promacta (eltrombopag) 12.5 mg oral suspension recalled were distributed to specialty pharmacies across the United States. Novartis identified the following lots that must be recalled because of the suspected peanut flour infiltration: Lot 8H57901589 with an expiration date of September 2020, Lot 9H57900189 with an expiration date of December 2020, and lot number Lot 9H57900289, also with an expiration date of December 2020.
Novartis stated that any patients who have the contaminated lots must stop taking them immediately. Novartis asked that the patient contact the company via the Novartis’ recall hotline number found on the company’s website. Patients must consult their physicians immediately to obtain a replacement prescription.
Pharmacies who have the contaminated drug must not dispense any additional doses of Promacta (eltrombopag)12.5 mg oral suspension and contact the company without delay for instructions on how to return the product to Novartis safely.
The FDA announced the recall on its webpage on May 12, 2019.
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