FDA-Drug2014-05-28Class I

Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02

Ben Venue Laboratories Inc
Hazard

Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution

Sold states
Nationwide.
Affected count
5,131 vials
Manufactured in
300 Northfield Rd, N/A, Bedford, OH, United States
Products
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1326-2014

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