Mylan UK informs MHRA of crystalline precipitate in antipsychotic medicine

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Xtockimages)
(Image: Getty/Xtockimages)

Related tags: Mylan, Aripiprazole, Mhra

The UK’s MHRA issues a drug alert regarding aripiprazole oral solution, but no recall is issued due to concerns over supply.

In a brief drug alert​, the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) noted that it had received an update from Mylan in regard to its aripiprazole 1mg/ml oral solution.

According to the company, it received a complaint concerning crystalline precipitate being observed within a bottle of the product.

The problem is anticipated to potentially affect three batches of the product – however, no recall has been initiated.

The MHRA explained, “Due to concerns with continuity of supply these batches are not being recalled at this time.”

Despite no recall being issued, healthcare professionals were advised to visually inspect the product prior to administration to ensure the product is clear of crystalline precipitate.

Aripiprazole is used to treat schizophrenia in adults or teenagers. It is also used alone or alongside other medications to treat episodes of mania or mixed episodes, and for various other neurological conditions.

Though not specific to this particular medicine, the Institute for Safe Medication Practices noted​ that delivering a product with such precipitate could lead to failure of the therapy due to drug inactivation, as well as potentially causing direct harm to the patient.

A spokesperson for Mylan was not immediately available for comment.

Related topics: Markets & Regulations, Regulations

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