The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1156-2016·Announced 2016-07-13

Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

Cantrell Drug Company is recalling fentanyl citrate injection syringes because they contain less active drug than labeled.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences from a subpotent drug.

Plain-English summary

Cantrell Drug Company is voluntarily recalling fentanyl citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL, in 1 mL and 3 mL syringes. The recall was initiated because the product is subpotent, meaning it contains less active drug than stated on the label.

The affected products are identified by specific lot numbers and expiration dates: 1 mL syringes (Lots 148292, exp 11/9/15 and 150610, exp 1/6/16) and 3 mL syringes (Lots 6208, exp 9/16/15 and 6851, exp 1/19/16). A total of 564 one-mL syringes and 1,146 three-mL syringes were distributed nationwide.

This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death. Patients and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found.

The recalled product

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
Manufacturer
Cantrell Drug Company
Category
Drug — Injectable
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Cantrell Drug Company under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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