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Dr. Reddy's Laboratories Recalls Sapropterin Dihydrochloride Powder Over Potency Concerns
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Dr. Reddy's Laboratories Recalls Sapropterin Dihydrochloride Powder Over Potency Concerns
Apr 23, 2024 1:33 PM

04:25 PM EDT, 04/23/2024 (MT Newswires) -- Dr. Reddy's Laboratories (RDY) said Tuesday it is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder 100 mg from the consumer market due to discoloration in some packets, which might reduce potency.

An accelerated stability test and customer complaints triggered the recall, the company said. Reduced product effectiveness may raise Phenylalaninemia levels in patients, and a chronic case may cause permanent intellectual disability, developmental delays and seizures in an infant or child, the company said.

The company said it has not received any adverse event reports linked to this recall.

The US Food and Drug Administration was notified about the recall, the company said.

Shares of the company were little changed in after-hours trading. They fell 0.9% in the regular session Tuesday.

Price: 71.49, Change: -0.03, Percent Change: -0.04

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