Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
FDA recall notice · announced May 28, 2014 · Ben Venue Laboratories
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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
Notes
Distribution: Nationwide.
Lot/code information: 2005479, Exp 03/14
Quantity: 5,131 vials
Status: Terminated
Products in this recall event:
- Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02 (D-1326-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.