September 2019 FDA Recall Bacteriostatic Water by Pfizer Inc.
D-1852-2019 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Pfizer Inc. on September 6, 2019 for the product Bacteriostatic Water. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1852-2019
Lack of Assurance of Sterility
09-06-2019
09-18-2019
185,700 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide US and Puerto Rico
03-25-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : W20308, Exp. Dec 1, 2019
