Recall: D-0485-2024

Class I - Dangerous

Class IClassification

2024-04-08Initiated

OngoingStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Javygtor (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 43598-097-30.

Reason

Sub-potent Drug; powder discoloration associated with decreased potency

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.