D-1326-2014 Class I Terminated
FDA drug recall D-1326-2014 was initiated by Ben Venue Laboratories Inc on February 14, 2014 and is designated Class I. 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 The recall status is terminated (terminated June 29, 2015). Affected quantity: 5,131 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2014
- Initiation Date
- February 14, 2014
- Termination Date
- June 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,131 vials
Product Description
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 Pattern
Nationwide.
Code Information
2005479, Exp 03/14