Class III · Low risk Ongoing
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc…
Reason Failed Impurities/Degradation Specifications
Is Sapropterin recalled?
4 FDA recalls mention Sapropterin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sapropterin.
Class I · High risk Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's…
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk Ongoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor…
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class III · Low risk Terminated
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's…
Reason Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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