Recalls / Class I
Class ID-1152-2016
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 in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450
- Affected lot / code info
- Lot: 6234, exp 9/20/15
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
- 884 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-1152-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.