Safety Alerts & Recalls

What does this mean?

This recall for Acetylcysteine Solution 10%, 30 mL per vial from Ben Venue Laboratories, Inc. was issued to the patient level and should be taken seriously because of the risks associated with possibly inhaling or ingesting glass particles. Patients who may have received product dispensed from lot 2005479 should not use these vials and should return the product to their pharmacist for replacement.

If you think you have or someone you care for has used vials from this lot, or if you have any concerns about this recall, please follow up with your healthcare provider as soon as possible.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/medwatch

Ben Venue Laboratories, Inc. Recalls Single Lot of Acetylcysteine Solution 10%, 30 mL Vial

Ben Venue Laboratories, Inc. has issued a nationwide voluntary product recall of Acetylcysteine Solution 10%, 30 mL per vial. Lot 2005479 was recalled after a single visible glass particle was discovered in a vial from this lot. There have been no complaints or adverse events related to pieces of glass in vials of this lot.

Acetylcysteine is usually delivered via a nebulizer. Because of this, glass particles in a vial can obstruct the airway and cause choking, wheezing, difficulty breathing, coughing, choking, and other complications which could be life-threatening.

Acetylcysteine by nebulizer is used by patients with decreased mucous secretions. Acetylcysteine, administered orally, is used as an antidote to prevent or lessen liver injury which may occur after acetaminophen overdose.

No other lots, strengths, or brands of acetylcysteine were involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-02-20
Last Updated: 2014-02-20

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