Drug recall: fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug…
Class I FDA enforcement event 72028. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Stability Data Does Not Support Expiry
Class I, in the words of FDA
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
Cantrell Drug Company started this drug recall on 21 Aug 2015. The firm address in the FDA record is in Little Rock, AR. FDA put the recall in Class I. FDA event 72028 has 13 product records. The first FDA enforcement report date is 13 Jul 2016. The record gives the status Terminated, with the termination date 3 Feb 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Cantrell Drug Company, Little Rock, AR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
13 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1152-2016 | 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 | 884 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1153-2016 | Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453 | a) 450 syringes and b) 1250 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1154-2016 | fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131 | 42 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1155-2016 | fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301 | 235 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1156-2016 | 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 | a) 564 syringes and b) 1146 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1157-2016 | fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491 | 148 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1158-2016 | 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 | 1652 syringes | Class I | Terminated | 13 Jul 2016 |
| D-1159-2016 | HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212 | 352 syringes | Class II | Terminated | 13 Jul 2016 |
| D-1160-2016 | HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163 | 4170 syringes | Class II | Terminated | 13 Jul 2016 |
| D-1161-2016 | LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033 | 450 syringes | Class II | Terminated | 13 Jul 2016 |
| D-1162-2016 | Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455 | 3853 syringes | Class II | Terminated | 13 Jul 2016 |
| D-1163-2016 | MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721 | 212 syringes | Class II | Terminated | 13 Jul 2016 |
| D-1164-2016 | MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161 | 1570 syringes | Class II | Terminated | 13 Jul 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class I
- 17%
- Product records in this event
- 13Median of the firm: 18
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jul 2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Compa | Drug | Class II | 18 |
| 18 Nov 2016 | Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantre | Drug | Class II | 21 |
Official channels
- FDA enforcement report D-1152-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 72028. https://recallregister.com/fda/i/72028/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 72028?
- The event has 13 product records. The first record gives this quantity:
884 syringes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 17% of the 292 drug events that started in 2015 are in Class I.