FDAClass IISeptember 18, 2019

Bacteriostatic Water for Injection recall: Sterility Concern

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…

Why was Bacteriostatic Water for Injection recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: W20308, Exp. Dec 1, 2019

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…
Recalling firm
Pfizer Inc.
Quantity
185,700 vials
Distribution
Nationwide US and Puerto Rico
Recall date
September 18, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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