Sterile Water Injection (Pfizer) – Non-Sterile Vials (2017)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Lot: 63-075-DK Exp. FEB 2019
Products Sold
Lot: 63-075-DK Exp. FEB 2019
Pfizer Inc. is recalling Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., L due to Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026