FDA Recall D-1158-2016
Cantrell Drug Company · Little Rock, AR
Class I — life-threatening Terminated 532 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-1158-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2015-08-21
- Classified by FDA Center
- 2016-07-06
- FDA published
- 2016-07-13
- Terminated
- 2017-02-03
- Recalling firm
- Cantrell Drug Company
- Firm location
- Little Rock, AR