FDA MedWatch - Sapropterin Dihydrochloride Powder for Oral Solution 100 mg by Dr. Reddy's

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TOPIC: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg by Dr. Reddy's: Recall - Due to Sub-Potency

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: Dr. Reddy's is recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.

Risk Statement: Reduced efficacy of the product would result in elevated Phenylalaninemia (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. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.

Dr. Reddy’s Laboratories has not received any reports of adverse events related to this recall to date.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately.

• Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product.

• Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase.

• Consumers with questions regarding this recall can contact Dr. Reddy’s Laboratories Inc. by calling 866-733-3952.

Health professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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