Critical Recall: Glass Particulate in Pfizer Drugs - MedWaste Management Critical Recall: Glass Particulate in Pfizer Drugs - MedWaste Management

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Nationwide Recall, Pfizer drugs contain glass particles

Critical Recall: Glass Particulate in Pfizer Drugs

We recently reported on an FDA recall involving one lot of Bleomycin due to glass particulate matter found in the intravenous medication. The drug’s manufacturer, Hospira, Inc. (a Pfizer company), is now initiating another nationwide recall due to the potential that the glass matter has made its way into other medications during manufacturing. The particulate matter is extremely dangerous when administered to patients. All pharmacies and medical professionals are strongly urged to check their stock and remove any affected vials.

As of the writing of this notice, no adverse events related to the particulate have yet been reported.

SUMMARY

Date of Recall:

Announced: December 21, 2023

Public Notification: December 26, 2023

Name(s) of Drug:

4.2% Sodium Bicarbonate Injection

8.4% Sodium Bicarbonate Injection

Atropine Sulfate Injection

Company Name:

Hospira, Inc. (a Pfizer company)

Brand Name:

Hospira

Drug Indication:

Electrolyte Replenishment

Metabolic Acidosis

Drug Intoxication

Severe Diarrhea

Cardiac Arrest

Mushroom Poisoning

And more…

Sodium Bicarbonate Injection Recall Sodium Bicarbonate Injection Recall Atropine sulfate recall

Product Description

Health systems nationwide (and in Puerto Rico) received distributions of medication vials between March 14, 2023, and June 29, 2023. The drugs are packaged in glass vials with yellow flip-top lids. Each drug name is clearly printed on the label, along with the lot number and expiration date.

Reason for Recall

A customer reported the presence of particulate matter in a vial of medication to the manufacturer. Hospira initiated an immediate recall of that medication as well as inspection procedures. Inspectors noted that the manufacturing process allows for the possibility of more glass particulate matter in the drugs mentioned.

Recall Impacts

Patients who receive an intravenous injection of glass particulate matter containing drug may experience serious adverse health effects, including:

  • Injection site pain
  • Vein Inflammation
  • Blood clots
  • Stroke
  • Death

Recall Lot Information

All wholesalers, pharmacies, and medical institutions are urged to check their stock for the presence of the drug. Compare existing stock with the product information in the chart below. Remove any stock that matches the drug name, strength, NDC number, lot number, and expiration date from circulation. Follow the recall procedures listed below.

Product
 
NDC
Lot Number
Expiration Date
Presentation
Count
4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe

Carton: 0409-5534-24

Case: 0409-5534-14

GX1542 1Jan2025 5 mEq/10 mL

(0.5 mEq/mL)

1-10 mL Abboject Syringe per carton

10 cartons per bundle

Case Pack 5 X 10-10 mL

8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe

Carton: 0409-6637-24

Case: 0409-6637-14

HA7295 1MAR2025 50 mEq/50 mL

(1 mEq/mL)

1-50 mL Abboject Syringe per carton

10 cartons per bundle

Case Pack 5 X 10-10 mL

Atropine Sulfate Injection, USP Lifeshield® ABBOJECT® Glass Syringe

Carton: 0409-4911-11

Case: 0409-4911-34

GY2496 1FEB2025 1 mg/10 mL

(0.1 mg/mL)

1-10 mL Abboject Syringe per carton

10 cartons per bundle

Case Pack 5 X 10-10 mL

FDA.gov

Have you found that medication in your stock is part of the recall? Here’s what you should do:

Health Systems

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick Inc. at 1 (800) 805-3093 for assistance.
  3. If you have additional questions, contact Pfizer Medical Information at 1 (800) 438-1985, option 3. They are available Monday-Friday from 9:00 a.m. to 5:00 p.m. ET. You may also contact them online at www.pfizermedinfo.com.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick Inc. at 1 (800) 805-3093 for assistance.
  3. If you have additional questions, contact Pfizer Medical Information at 1 (800) 438-1985, option 3. They are available Monday-Friday from 9:00 a.m. to 5:00 p.m. ET. You may also contact them online at www.pfizermedinfo.com.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, Nurse Writer

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

One response

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    I thought you did a great job here. The wording is excellent and the illustration is tasteful, but there’s a feeling that you might be giving more, which would probably happen again if you go on this walk.


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