Sandoz growth disorder drug recalled over vial defects

Taipei, July 29 (CNA) The Taiwan Food and Drug Administration (TFDA) has ordered a recall of 5,152 vials of a growth disorder medication after defects were found in the necks of the drug's containers, raising concerns over product quality.

The recalled product is "Omnitrope Sandoz injection 5mg/1.5ml," manufactured by Sandoz Pharmaceutical Taiwan Co., the agency confirmed Wednesday. The recall involves batch number PR7349, with the company required to complete the recall by Aug. 8.

The TFDA said the drug manufacturer notified it of the existence of defective vials after customers complained that the necks of some of the containers had broken.

TFDA official Liu Chia-ping (劉佳萍) said an investigation found the damage likely occurred during the production process because a manufacturing tool had not been properly adjusted, causing it to strike the neck of the vials.

Omnitrope is used to treat several types of growth disorders, including those caused by insufficient growth hormone secretion from the pituitary gland, chronic kidney disease-related growth problems, and severe growth hormone deficiency in adults.

The FDA said it has asked the company to submit an investigation report and corrective measures after completing the recall. Failure to comply could result in a fine of between NT$200,000 (US$6,200) and NT$5 million, as stipulated in the Pharmaceutical Affairs Act.

The agency said other batches of the medication were not affected and will continue to be imported, with no shortage expected.