Drug recall: Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only…
Class II FDA enforcement event 75745. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Cantrell Drug Company started this drug recall on 18 Nov 2016. The firm address in the FDA record is in Little Rock, AR. FDA put the recall in Class II. FDA event 75745 has 21 product records. The first FDA enforcement report date is 21 Dec 2016. The record gives the status Terminated, with the termination date 29 Apr 2020.
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
21 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0184-2017 | Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37 | 80 bags | Class II | Terminated | 21 Dec 2016 |
| D-0185-2017 | Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12 | 30,796 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0186-2017 | Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-102-09 | 73 bags | Class II | Terminated | 21 Dec 2016 |
| D-0187-2017 | Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207 | 645 vials | Class II | Terminated | 21 Dec 2016 |
| D-0188-2017 | Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35 | 471 bags | Class II | Terminated | 21 Dec 2016 |
| D-0189-2017 | Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61 | 2545 bags | Class II | Terminated | 21 Dec 2016 |
| D-0190-2017 | Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75 | 2889 bags | Class II | Terminated | 21 Dec 2016 |
| D-0191-2017 | Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15 | 48,592 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0192-2017 | Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16 | 1494 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0193-2017 | Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24 | 150 bags | Class II | Terminated | 21 Dec 2016 |
| D-0194-2017 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03 | 2509 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0195-2017 | HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04 | 935 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0196-2017 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10 | 93 vials | Class II | Terminated | 21 Dec 2016 |
| D-0197-2017 | Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207 | 162 syringe | Class II | Terminated | 21 Dec 2016 |
| D-0198-2017 | Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04 | 37 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0199-2017 | Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75 | 1748 bags | Class II | Terminated | 21 Dec 2016 |
| D-0200-2017 | Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15 | 24,547 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0201-2017 | Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30 | 2681 bags | Class II | Terminated | 21 Dec 2016 |
| D-0202-2017 | Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15 | 5067 syringes | Class II | Terminated | 21 Dec 2016 |
| D-0203-2017 | Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75 | 87 bags | Class II | Terminated | 21 Dec 2016 |
| D-0204-2017 | Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12 | 9859 syringes | Class II | Terminated | 21 Dec 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 II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2016
- 288
- Share of these events in Class II
- 46%
- Product records in this event
- 21Median 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 |
| 21 Aug 2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co. | Drug | Class I | 13 |
Official channels
- FDA enforcement report D-0184-2017The 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 75745. https://recallregister.com/fda/ii/75745/. 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 75745?
- The event has 21 product records. The first record gives this quantity:
80 bags
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2016 have the same class?
- 46% of the 288 drug events that started in 2016 are in Class II.