Home / Recalls / Dr. Reddy's Laboratories, Inc. / D-0007-2023

D-0007-2023 Class III

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

Recall Details

Product Type
Drugs
Report Date
October 12, 2022
Initiation Date
September 14, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,838 ampules

Product Description

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

Reason for Recall

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Distribution Pattern

USA nationwide

Code Information

Lot # ACB101, Exp 03/2023

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-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)
  • D-0027-2025 Class II — Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories I (October 9, 2024)
  • D-0026-2025 Class II — Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories In (October 9, 2024)