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.
Reported: May 15, 2024 Initiated: April 8, 2024 #D-0485-2024
Product Description
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 for Recall
Sub-potent Drug; powder discoloration associated with decreased potency
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 17,332 cartons
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 17,332 cartons.
Why was this product recalled? ▼
Sub-potent Drug; powder discoloration associated with decreased potency
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2024. Severity: Critical. Recall number: D-0485-2024.
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