Drug product
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
D-1326-2014
Product summary
- Event
- Event 67512
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,131 vials
- Official record key
drug-enforcement:D-1326-2014
Official wording
Reason: Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Code information: 2005479, Exp 03/14
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter