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MS Diagnostic Laboratory, 128 West Olive Avenue, MONROVIA, CA, 91016, USA

Latest report: April 7, 2021 12:00 PM
EJ

Covid-19 OSHA Complaint

2 years ago

T8CCR 5193(d)(3)(A)- The use of needles with engineered sharps injury protection for drawing patient blood has been discontinued. Employees have now been required to remove the needle from the needle hub to be re-used. T8CCR 3203(a)(4)- Employer has placed a machine analyzing COVID-19 blood samples in the... See More supply room where employees are accessing for lap supplies.

Alleged Hazards: 2, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-02-25
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322


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Hospira, Inc., a Pfizer company, is voluntarily recalling 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 due to the potential presence of glass particulate matter. To... See More date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from October 13, 2022 through October 26, 2022.

The recalled products are:
- 4.2% Sodium Bicarbonate Injection, USP Glass ABBOJECT® Syringe, NDC: Carton 0409-5534-24. Case: 0409-5534-14. Lot: 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
- 1% Lidocaine HCl Injection, USP LIFESHIELD® Glass ABBOJECT® Syringe. NDC: Carton 0409-4904-11 Case 0409-4904-34. Lot: 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
- 2% Lidocaine HCl Injection, USP LIFESHIELD® Glass ABBOJECT® Syringe. NDC: Carton 0409-4903-11 Case 0409-4903-34. Lot: GH6567. ExpirationDate: 1JUL2024. Presentation: 100 mg/5mL (20 mg/mL). Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 5mL

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.

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.

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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.

Company name: Hospira, Inc.
Brand name: Hospira
Product recalled: 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP
Reason of the recall: Potential Presence of Glass Particulates
FDA Recall date: October 02, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-42-sodium-bicarbonate-injection-usp-and-1-and-2
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