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Cetylev FDA Alerts

The FDA Alerts below may be specifically about Cetylev or relate to a group or class of drugs which include Cetylev.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Cetylev

Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution: Recall - Inadequate Seal of Blister Pack

ISSUE: Arbor  Pharmaceuticals, LLC announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.

The improper seal of the product can lead to a potentially sub-therapeutic dose as well as potential microbial contamination. Because the effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen is delayed with decreased therapy, sub-therapeutic dosing could lead to increased risk of liver injury. With regards to the potential microbial contamination due to moisture ingress into the tablets, the risk of serious infection is increased in certain patient populations such as children, pregnant women, immunosuppressed patients, and patients on gastric acid suppression therapy such as proton pump inhibitors.

Three lots of the 500 mg strength (Lot Numbers 005C16, 006C16, and 007C16, expiration date 02/2018) with NDC 24338-700-10 are included in the recall.

BACKGROUND: Cetylev (acetylcysteine) effervescent tablets for oral solution are indicated as an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion.

RECOMMENDATION: Healthcare facilities should immediately discontinue use from these lots of product and return all unused Cetylev to Arbor. Consumers with questions regarding this recall should contact Arbor Pharmaceuticals, LLC at 1-866-516-4950, Monday through Friday, during business hours of 9:00 am to 5:00 pm, Eastern Standard Time (EST).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[08/18/2016 - Press Release - Arbor Pharmaceuticals]


Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product

ISSUE: Ben Venue Laboratories notified health professionals and their medical care organizations of a nationwide product recall of Acetylcysteine Solution 10%, manufactured for Roxane Laboratories, NDC #0054-3025-02 – Lot 2005479 – Exp. Date March 2014. The recall was initiated on February 14, 2014 after the discovery of a single visible glass particle in a vial within the lot listed above. The nationwide voluntary recall is to the patient level. This recall is limited to lot number 2005479.

Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions).

BACKGROUND: Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. It is usually delivered via a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchoscopy.

RECOMMENDATION: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lot listed above for patient care and should immediately quarantine any product for return. Patients who may have received product dispensed from this one lot should return the product to their pharmacist. Distributors/retailers that have not received a recall packet should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI 53218.

 

[02/14/2014 - Press Release - Ben Venue Laboratories ]


Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

ISSUE: Bedford Laboratories issued an update to the voluntary recall, initiated December 20, 2011 of one lot of Acetylcysteine Solution (Roxane Laboratories) due to the discovery of a single visible glass particle in a vial within the lot. Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions).

BACKGROUND: The single lot is identified as Lot 1877093 – Exp. Date June 2013. Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. Acetylcysteine for inhalation is usually delivered via a Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or into the bronchial-pulmonary tree during bronchosopy.

RECOMMENDATION: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lot listed above for patient care and should immediately quarantine any product for return. Patients that may have received product dispensed from this one lot should return the product to their pharmacist.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[02/02/2012 - Press Release - Bedford Laboratories]


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