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Class II: temporary or reversible health riskTerminated

Pfizer Sterile Water for Inj Recall

Sterile Water for Inj

Pfizer Inc. · New York, NY

Risk level
Class II
Reported by FDA
May 26, 2021
Recall ID
D-0384-2021
Check your lot numberHow we source this data

Summary

Pfizer recalled Sterile Water for Inj starting May 3, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0384-2021 on May 26, 2021. Reason: Presence of Particulate Matter: particulate matter identified as an insect in one vial. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot DN9185

Where it was sold

Nationwide USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0384-2021
Classification
Class II
Status
Terminated
Recall initiated
May 3, 2021
FDA report date
May 26, 2021
Quantity
49,525 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Pfizer Inc.

Original FDA data

Every field from FDA enforcement report D-0384-2021, exactly as published.

Show all FDA fields
City
New York
State
NY
Status
Terminated
Country
United States
Event ID
87831
Address
235 East 42nd Street
Code information
Lot DN9185
Postal code
10017-5703
Report date
May 26, 2021
Product type
Drugs
Recall number
D-0384-2021
Classification
Class II
Recalling firm
Pfizer Inc.
Product quantity
49,525 vials
Termination date
Jul 29, 2023
Reason for recall
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide USA
Recall initiation date
May 3, 2021
Initial firm notification
Letter
Center classification date
May 14, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0384-2021, published May 26, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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