Home / Recalls / Pfizer Inc. / D-0384-2021

D-0384-2021 Class II Terminated

Recalled by Pfizer Inc. — New York, NY

Recall Details

Product Type
Drugs
Report Date
May 26, 2021
Initiation Date
May 3, 2021
Termination Date
July 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49,525 vials

Product Description

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

Reason for Recall

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Distribution Pattern

Nationwide USA

Code Information

Lot DN9185

Other recalls by Pfizer Inc.

  • D-0591-2025 Class II — Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx o (August 4, 2025)
  • D-0590-2025 Class II — Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distribut (August 4, 2025)
  • D-0575-2025 Class II — Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, (July 29, 2025)
  • D-0545-2025 Class II — Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units pe (July 10, 2025)
  • D-0544-2025 Class II — Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per (July 10, 2025)
  • D-0489-2025 Class II — DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial (May 28, 2025)
  • D-0564-2024 Class II — Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpujec (May 20, 2024)
  • D-0565-2024 Class II — Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C (May 20, 2024)
  • D-0235-2024 Class I — Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJE (December 21, 2023)
  • D-0261-2024 Class I — Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop via (December 21, 2023)