Drug recall D-0485-2024

Class I Ongoing reported May 15, 2024

Product

Javygtor (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 43598-097-30.

Reason for recall

Sub-potent Drug; powder discoloration associated with decreased potency

Lots and codes

Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
17,332 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
April 8, 2024

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