FDA-Drug2022-03-02Class III
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Dr. Reddy's Laboratories, Inc.
Hazard
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Sold states
Nationwide in the USA.
Affected count
340 packets
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0640-2022Don't want to check this manually?
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