FDA recall D-1326-2014

Ben Venue Laboratories Inc · Class I · drug

Product

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2014-02-14
Report date
2014-05-28
Termination date
2015-06-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bedford, OH, United States

Primary source

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