FDAFDA · Food and drugs·Recall number D-0640-2022
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).
Published March 2, 2022 · Recall initiated: February 17, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- T2100891, Exp. 02/28/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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