Home / Recalls / Ascend Laboratories, LLC / D-1145-2023

D-1145-2023 Class III Terminated

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
September 13, 2023
Initiation Date
July 18, 2023
Termination Date
February 19, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
99,516 sachets

Product Description

Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57

Reason for Recall

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Distribution Pattern

The recall product was distributed nationwide.

Code Information

Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.

Other recalls by Ascend Laboratories, LLC

  • D-0017-2026 Class II — Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-5 (September 19, 2025)
  • D-0018-2026 Class II — Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-9 (September 19, 2025)
  • D-0020-2026 Class II — Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90) (September 19, 2025)
  • D-0019-2026 Class II — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90) (September 19, 2025)
  • D-0645-2025 Class II — Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Al (August 28, 2025)
  • D-0576-2025 Class II — Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx On (July 21, 2025)
  • D-0534-2025 Class II — Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, M (July 9, 2025)
  • D-0533-2025 Class II — Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Ma (July 9, 2025)
  • D-0469-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx On (May 23, 2025)
  • D-0468-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx On (May 23, 2025)