FDA Recall D-1326-2014
Ben Venue Laboratories Inc · Bedford, OH
Class I — life-threatening Terminated 500 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-1326-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide.
- Recall initiated
- 2014-02-14
- Classified by FDA Center
- 2014-05-19
- FDA published
- 2014-05-28
- Terminated
- 2015-06-29
- Recalling firm
- Ben Venue Laboratories Inc
- Firm location
- Bedford, OH