Drug Enforcement D-0485-2024

Sub-potent Drug; powder discoloration associated with decreased potency

Status

Ongoing

Classification

Class I

Report Date

May 15, 2024

Termination Date

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Product Information

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.
Product quantity
17,332 cartons
Reason for recall
Sub-potent Drug; powder discoloration associated with decreased potency
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0485-2024
Event ID
94369
Recall initiation date
April 8, 2024
Center classification date
May 6, 2024
Code info
Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
More code info
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