Reported Dec 18, 2024 · Ongoing
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04
- Lot codes and dates
Lot #: T2300653Exp 01/31/2025T2303956T2303750Exp 06/30/2025T2304190T2304987Exp 08/31/2025T2302026Exp 03/31/2025T2302526Exp 05/31/2025
- Amount recalled
- 7,233 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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