Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride

Dr. Reddy’s Laboratories Ltd., a leading pharmaceutical company, announced a voluntary nationwide recall of six (6) specific lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg. This recall is due to powder discolouration observed in some packets, which could decrease the medication’s potency.

Cause of the Recall

The issue with powder discolouration was discovered during routine accelerated stability testing, a process that simulates long-term storage conditions to assess medication stability. Additionally, customer complaints prompted further investigation.

The primary concern associated with this recall is the potential for reduced efficacy of the product. If a patient receives a discoloured packet with decreased potency, it could lead to elevated blood phenylalanine (Phe) levels. Chronically elevated Phe levels, particularly in infants and children, pose a significant health risk. Potential consequences include permanent neurocognitive deficits, such as intellectual disability, developmental delays, and seizures. For pregnant women, especially during early gestation, elevated Phe levels can be associated with microcephaly (abnormally small head size) and congenital heart disease in their babies.

Product Information and Actions to Take

The recalled product, Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, is indicated to help manage blood phenylalanine levels in patients with a specific genetic disorder called Phenylketonuria (PKU). It is specifically formulated for use by adults and paediatric patients one month of age and older diagnosed with tetrahydrobiopterin (BH4)–responsive PKU. The medication comes packaged in individual packets, with 30 packets per carton.

Dr. Reddy emphasises that no adverse events related to this recall have been reported to date. However, they urge healthcare professionals and patients to check the medication lot number. If the lot number falls within the 6 specific lots listed in the official recall notice, patients should discontinue using the medication and consult their healthcare provider for alternative treatment options. The company is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products.

About Dr Reddy’s Laboratories Ltd

Dr. Reddy’s Laboratories Ltd. operates a portfolio of products and services, including Active Pharmaceutical Ingredients (APIs), Custom Pharmaceutical services (CPS), generics, biosimilars, and differentiated formulations.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.