Recalls / Class I
Class ID-0485-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Javygtor
- Generic name
- Sapropterin Dihydrochloride
- Active ingredient
- Sapropterin Dihydrochloride
- Route
- Oral
- NDC
- 43598-097
- FDA application
- ANDA209452
- Affected lot / code info
- Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
Why it was recalled
Sub-potent Drug; powder discoloration associated with decreased potency
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 17,332 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-04-08
- FDA classified
- 2024-05-06
- Posted by FDA
- 2024-05-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0485-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.