Recalls / Class I
Class ID-1156-2016
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, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR
- Affected lot / code info
- a) Lots: 148292, exp 11/9/15 and 150610, exp 1/6/16 and b) Lots: 6208, exp 9/16/15 and 6851, exp 1/19/16
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
- a) 564 syringes and b) 1146 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-1156-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.