Recalls / Class I
Class ID-1697-2012
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
Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
- Affected lot / code info
- Lot #2067134 Exp 5/31/2013, NDC 55390-039-10
Why it was recalled
Presence of Particulate Matter
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
- 797 boxes/10/20 mg vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-06-26
- FDA classified
- 2012-09-26
- Posted by FDA
- 2012-10-03
- Terminated
- 2014-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1697-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.