FDA Drug Class I — Most Serious

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 43598-477-30.

Hazard

Sub-potent Drug; powder discoloration associated with decreased potency

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Products

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 43598-477-30.
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot # T2200352, Exp. 12/31/2024

Units Affected

2402 cartons

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