Dr Reddy’s initiates voluntary recall of Sapropterin Dihydrochloride in US over potency concerns – ET HealthWorld | Pharma

Hyderabad: Dr Reddy’s Laboratories Ltd on Tuesday informed the stock exchange that it has initiated a voluntary recall 100 mg in lots of six Sapropterin Dihydrochloride Powder for oral solution US market,

The company said that although it has not received any report of this adverse events Regarding the product recalled so far, a recall was initiated after powder was found in it discoloration In some packets, which may affect the potency of the medicine.

The company said the change in color was observed during accelerated stability testing and following customer complaints.

Sapropterin dihydrochloride is used to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older suffering from hyperphenylalaninemia (HPA) caused by tetrahydrobiopterin-(BH4-). reactive phenylketonuria (PKU).

While pH levels may increase in patients as a result of a reduction in drug potency or efficacy, it states that chronically elevated pH levels in infants and children may cause permanent neurocognitive deficits and higher levels during pregnancy have been linked to microcephaly. Having more congenital heart disease,

Dr Reddy’s It said the affected lots of the drug were distributed to wholesalers and retailers across the country and its US arm Dr. Reddy’s Laboratories Inc., is notifying its distributors and customers through recall notification letters and all the recalls Is arranging for the return of returned products.

  • Published on April 24, 2024 at 06:36 am IST

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