Recalls / Class I
Class ID-1326-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
- Affected lot / code info
- 2005479, Exp 03/14
Why it was recalled
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Recalling firm
- Firm
- Ben Venue Laboratories Inc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 300 Northfield Rd, N/A, Bedford, Ohio 44146
Distribution
- Quantity
- 5,131 vials
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-02-14
- FDA classified
- 2014-05-19
- Posted by FDA
- 2014-05-28
- Terminated
- 2015-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1326-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.