Class I

Drug Recall: Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

Dr. Reddy's Laboratories, Inc. · April 8, 2024

Reason for Recall

Sub-potent Drug; powder discoloration associated with decreased potency

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

2402 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0486-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.