Home / Recalls / Pfizer Inc. / D-1852-2019

D-1852-2019 Class II Terminated

Recalled by Pfizer Inc. — New York, NY

Recall Details

Product Type
Drugs
Report Date
September 18, 2019
Initiation Date
September 6, 2019
Termination Date
March 25, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
185,700 vials

Product Description

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide US and Puerto Rico

Code Information

Lot #: W20308, Exp. Dec 1, 2019

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  • 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-0565-2024 Class II — Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C (May 20, 2024)
  • D-0564-2024 Class II — Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpujec (May 20, 2024)
  • D-0261-2024 Class I — Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop via (December 21, 2023)
  • D-0233-2024 Class I — 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT (December 21, 2023)