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.
Recall Number: D-0486-2024
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class I
Status: Ongoing
Report Date: 20240515
Initiation Date: 20240408
Termination Date:
Reason for Recall
Sub-potent Drug; powder discoloration associated with decreased potency
Product Description
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.