Home / Recalls / Dr. Reddy's Laboratories, Inc. / D-0486-2024

D-0486-2024 Class I Ongoing

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

Recall Details

Product Type: Drugs
Report Date: May 15, 2024
Initiation Date: April 8, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2402 cartons

Product Description

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.

Reason for Recall

Sub-potent Drug; powder discoloration associated with decreased potency

Distribution Pattern

Nationwide in the USA

Code Information

Lot # T2200352, Exp. 12/31/2024

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D-0525-2025 Class II — Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manu (June 30, 2025)
D-0365-2025 Class I — Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x (March 13, 2025)
D-0117-2025 Class III — Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, (November 22, 2024)
D-0047-2025 Class III — IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Red (October 29, 2024)
D-0037-2025 Class II — Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Ma (October 22, 2024)
D-0036-2025 Class II — Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, (October 22, 2024)
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