Home / Recalls / Dr. Reddy's Laboratories, Inc. / D-0640-2022

D-0640-2022 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
March 2, 2022
Initiation Date
February 17, 2022
Termination Date
January 29, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
340 packets

Product Description

Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).

Reason for Recall

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

Distribution Pattern

Nationwide in the USA.

Code Information

T2100891, Exp. 02/28/2024

Other recalls by Dr. Reddy's Laboratories, Inc.

  • D-0219-2026 Class III — Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laborato (November 11, 2025)
  • D-0008-2026 Class II — Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Mul (September 26, 2025)
  • 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-0036-2025 Class II — Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, (October 22, 2024)
  • D-0037-2025 Class II — Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Ma (October 22, 2024)
  • D-0027-2025 Class II — Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories I (October 9, 2024)
  • D-0028-2025 Class II — Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories In (October 9, 2024)