FDA recall D-0486-2024

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.

Reason for recall

Sub-potent Drug; powder discoloration associated with decreased potency

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0486-2024