Home / Recalls / Amneal Pharmaceuticals LLC / D-0076-2018

D-0076-2018 Class II Terminated

Recalled by Amneal Pharmaceuticals LLC — Glasgow, KY

Recall Details

Product Type
Drugs
Report Date
November 22, 2017
Initiation Date
August 31, 2017
Termination Date
September 10, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,000 vials

Product Description

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

Reason for Recall

Presence of Particulate Matter

Distribution Pattern

MS, NC, OH, TX, UT

Code Information

Lot # AP160016; Exp. 05/18

Other recalls by Amneal Pharmaceuticals LLC

  • D-0618-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, M (August 18, 2025)
  • D-0615-2025 Class II — Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx (August 18, 2025)
  • D-0616-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Ma (August 18, 2025)
  • D-0619-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Ma (August 18, 2025)
  • D-0617-2025 Class II — chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Man (August 18, 2025)
  • D-0488-2025 Class I — Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Ta (June 2, 2025)
  • D-0402-2025 Class I — Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manu (April 17, 2025)
  • D-0629-2024 Class III — Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amn (August 1, 2024)
  • D-0614-2020 Class II — Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. (November 22, 2019)
  • D-0616-2020 Class II — Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. (November 22, 2019)