Dr Reddy's Laboratories on Tuesday said it is voluntarily recalling from the US market six lots of medication, indicated to reduce blood phenylalanine (Phe) levels, on account of being subpotent. The company is recalling affected lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discolouration in some packets leading to decreased potency, the Hyderabad-based drug maker said in a regulatory filing.

Reddy博士的实验室周二表示，他们自愿从美国市场召回了六批药物，这些药物被认为是亚能力的，可以降低血液中苯丙氨酸（Phe）的水平。这家总部位于海得拉巴的制药商在一份监管文件中表示，该公司正在召回受影响的大量盐酸沙丙蝶呤口服溶液粉末，使其达到消费者水平100毫克，因为某些包装中的粉末变色导致效力降低。

The issue was discovered during an accelerated stability test in addition to customer complaints, it added. Reduced efficacy of the product would result in elevated Phe levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures.

它补充道，除了客户投诉外，在加速稳定性测试期间还发现了该问题。该产品的功效降低会导致患者体内苯丙氨酸水平升高。婴儿和儿童的Phe水平长期升高可能会导致永久性神经认知缺陷，包括永久性和不可逆转的智力残疾，发育迟缓和癫痫发作。

Dr Reddy's Laboratories Inc, the US-based arm of the company, has not received any reports of adverse events related to this recall to date, the company said. Dr Reddy's Laboratories Inc is notifying its distributors and customers by recall notification letters and arranging for returns of all recalled products, it said.

该公司表示，该公司在美国的分支机构Reddy's Laboratories Inc迄今尚未收到任何与此次召回有关的不良事件报告。Reddy博士的实验室公司（Dr Reddy's Laboratories Inc）正在通过召回通知函通知其分销商和客户，并安排所有召回产品的退货，该公司表示。

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately, it added. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg from the affected lot should return it to their place of purchase, the company said.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

它补充说，任何拥有被召回产品现有库存的人都应该检查该产品，并立即隔离任何召回批次。该公司表示，从受影响批次中服用100毫克盐酸沙丙蝶呤口服液粉末的消费者应将其退回购买地。（您现在可以订阅我们的经济时报WhatsApp频道）（您现在可以订阅我们的经济时报WhatsApp频道）。