Recalls / Class I
Class ID-1158-2016
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
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
- Affected lot / code info
- Lot: 6324, exp 10/11/15
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, N/A, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 1652 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-21
- FDA classified
- 2016-07-06
- Posted by FDA
- 2016-07-13
- Terminated
- 2017-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1158-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.