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Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per ...

FDA Recall #D-0485-2024 — Class I — April 8, 2024

Recall #D-0485-2024 Date: April 8, 2024 Classification: Class I Status: Ongoing

Product Description

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

Recalling Firm

Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

17,332 cartons

Distribution

Nationwide in the USA

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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