Highest risk U.S. Food and Drug Administration

Hospira 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection recall: Potential Presence of Glass Particulates

Recall published 3+ years ago

Potential Presence of Glass Particulates

Hospira Prescription & OTC drugs — recalled prescription & otc drugsHospira Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Hospira Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 2, 2023
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Hospira
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP

What the company announced

FOR IMMEDIATE RELEASE - October 2, 2023 - NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated due to the potential for presence of glass particulate matter.

There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of an antiarrhythmic agent administered intravenously by either direct injection or continuous infusion. It is available in various concentrations. It is administered intravenously or intramuscularly and is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.

The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from October 13, 2022 through October 26, 2022.

  • Product: 4.2% Sodium Bicarbonate Injection, USP Glass ABBOJECT® Syringe · NDC: Carton 0409-5534-24 Case 0409-5534-14 · Lot Number: GJ5007 · Expiration Date: 1AUG2024 · Presentation: 5 mEq/10mL, (0.5 mEq/mL) · Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 10mL
  • Product: 1% Lidocaine HCl Injection, USP LIFESHIELD® Glass ABBOJECT® Syringe · NDC: Carton 0409-4904-11 Case 0409-4904-34 · Lot Number: 42290DK · Expiration Date: 1JUN2024 · Presentation: 50 mg/5mL (10 mg/mL) · Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 5mL
  • Product: 2% Lidocaine HCl Injection, USP LIFESHIELD® Glass ABBOJECT® Syringe · NDC: Carton 0409-4903-11 Case 0409-4903-34 · Lot Number: GH6567 · Expiration Date: 1JUL2024 · Presentation: 100 mg/5mL (20 mg/mL) · Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 5mL

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of a lot which is being recalled should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the information below.

  • Contact Center: Pfizer Medical Information · Contact Information: 1-800-438-1985, option 3 (8am to 7pm ET Monday through Friday) www.pfizermedinfo.com · Area of Support: For medical questions regarding the product
  • Contact Center: Pfizer Drug Safety · Contact Information: 1-800-438-1985, option 1 (24 hours a day; 7 days a week) · Area of Support: To report adverse events and product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • GJ5007
  • 42290DK
  • GH6567

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 1AUG2024
  • 1JUN2024
  • 1JUL2024

Model or item number

On the rating label, the box or the instruction sheet.

  • 4.2

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mL
  • 50 mg
  • 5 mL
  • 100 mg
  • 10 mg
  • 20 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Hospira — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Hospira, Inc. — Consumers: Sedgwick Inc., 1-800-805-3093 — Media: Media Relations, +1-212-733-1226, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Hospira prescription & otc drugs recalled?

Potential Presence of Glass Particulates There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code GJ5007, 42290DK, GH6567; best-by date 1AUG2024 or 1JUN2024; model number 4.2. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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