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Sandoz growth disorder drug recalled over vial defects
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Latest | FOCUS TAIWAN - CNA ENGLISH NEWS
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.
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.
The agency said other batches of the medication were not affected and will continue to be imported, with no shortage expected.