Uzbekistan Recalls Two Batches of Kantreykol Drug

Tashkent, Uzbekistan (UzDaily.uz) — Uzbekistan has ordered two batches of the Kantreykol (Aprotinin) drug to be withdrawn from circulation, destroyed and discontinued for medical use after laboratory tests found that they did not meet regulatory requirements, the State Institution Center for Pharmaceutical Products Safety under the Ministry of Health said.

The measure concerns Kantreykol in the form of a lyophilizate for preparing a solution for injection, with a dosage of 10,000 ATrE and a package containing 10 vials. The non-compliance was identified following laboratory testing of samples taken from individual batches of the medicine.

Center specialists purchased the samples as part of control measures conducted by the Center for Pharmaceutical Products Safety’s post-registration surveillance department.

The order applies to the drug manufactured by the British-Georgian joint venture Yevro Medical in Georgia. Two batches are subject to withdrawal: batch 870725, with an expiry date of July 2028, and batch 791224, expiring in December 2027.

Businesses engaged in the wholesale and retail sale of medicines and medical products have been instructed to completely discontinue medical use of the specified batches, withdraw them from circulation and destroy them in accordance with established procedures.

The Center also reminded businesses of existing requirements governing the circulation of medicines. Storing or selling medicines and medical products without a certificate of conformity, as well as storing and selling drugs that fail to meet quality requirements, constitute serious violations of licensing requirements and conditions.

The legislation provides for liability for such violations. A license may be revoked in accordance with established procedures, while administrative or criminal liability may also apply.

The Center for Pharmaceutical Products Safety said it will continue control measures aimed at removing Kantreykol from circulation and ensuring compliance with established requirements.