Key Takeaway
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, ND by Dr. Reddy's Laboratories, Inc. was recalled on February 17, 2022. The hazard: Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, ND
Description
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Hazard / Reason
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class III: Product that is not likely to cause adverse health consequences.
Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.
Products Affected
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, ND
DrugsCompany Information
Dr. Reddy's Laboratories, Inc.
Bridgewater, NJ, United States
View all 163 recalls by Dr. Reddy's Laboratories, Inc. →Distribution
Nationwide in the USA.
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.