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Recall Observatory FDA recall evidence

Drug 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.

D-0485-2024

April 08, 2024

Class I

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 94369
Status
Ongoing
Classification
Class I
Quantity
17,332 cartons
Official record key
drug-enforcement:D-0485-2024

Official wording

Reason: Sub-potent Drug; powder discoloration associated with decreased potency

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub-potent Drug; powder discoloration associated with decreased potency