Class I
Ongoing
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.
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- April 8, 2024
- Posted
- May 15, 2024
- Recall Number
- D-0486-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2402 cartons
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Sub-potent Drug; powder discoloration associated with decreased potency
Distribution
Nationwide in the USA
Lot / Code Info
Lot # T2200352, Exp. 12/31/2024
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