Dr. Reddy's Laboratories, Inc. recalls Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr.
Recalled May 15, 2024 · FDA recall D-0486-2024 · Dr. Reddy's Laboratories
Hazard
Sub-potent Drug; powder discoloration associated with decreased potency · FDA Class I
Units
2402 cartons
Sold at
Nationwide in the USA
Description
Sub-potent Drug; powder discoloration associated with decreased potency
Product
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.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →