Cantrell Drug Company: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Agency Publication Date: December 13, 2016

Affected Products

Product: 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

Lot: 169170

Lot Numbers:

169170

Product: 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

Lot: 8502 BUD: 11/21/2016, Lot: 8962 BUD: 02/21/2017

Lot Numbers:

8502

8962

Product: 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

Lot: 168032

Lot Numbers:

168032

Product: 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

Lot: 169924

Lot Numbers:

169924

Product: 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

Lot: 9002

Lot Numbers:

9002

Product: 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

Lot: 8990

Lot Numbers:

8990

Product: 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

Lot: 8942 BUD: 2/19/2017, Lot: 9207 BUD: 4/17/2017

Lot Numbers:

8942

9207

Product: 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

Lot: 9006 BUD: 1/20/2017, Lot: 8757 BUD: 11/30/2016, Lot: 8954 BUD: 1/6/2017, Lot: 9174 BUD: 2/20/2017

Lot Numbers:

9006

8757

8954

9174

Product: 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

Lot: 9220

Lot Numbers:

9220

Product: 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

Lot: 167081

Lot Numbers:

167081

Product: 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

Lot: 8742

Lot Numbers:

8742

Product: 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

Lot: 9016 BUD: 3/7/2017

Lot Numbers:

9016

Product: 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

Lot: 163941

Lot Numbers:

163941

Product: Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207

Lot: 165538

Lot Numbers:

165538

Product: 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

Lot: 169619

Lot Numbers:

169619

Product: 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

Lot: 8625

Lot Numbers:

8625

Product: 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

Lot: 8997 BUD: 12/1/2016, Lot: 9246 BUD: 1/23/2017

Lot Numbers:

8997

9246

Product: 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

Lot: 9210

Lot Numbers:

9210

Product: 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

Lot: 8995

Lot Numbers:

8995

Product: 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

Lot: 169064

Lot Numbers:

169064

Product: 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

Lot: 169262 BUD: 1/8/2017, Lot: 169812 BUD: 1/19/2017

Lot Numbers:

169262

169812

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75745

Status: Resolved

Manufacturer: Cantrell Drug Company

Manufactured In: United States

Units Affected: 21 products (80 bags; 30,796 syringes; 73 bags; 645 vials; 471 bags; 2545 bags; 2889 bags; 48,592 syringes; 1494 syringes; 150 bags; 2509 syringes; 935 syringes; 93 vials; 162 syringe; 37 syringes; 1748 bags; 24,547 syringes; 2681 bags; 5067 syringes; 87 bags; 9859 syringes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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

Lot: 169170

Lot Numbers:

169170

Product: 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

Lot: 8502 BUD: 11/21/2016, Lot: 8962 BUD: 02/21/2017

Lot Numbers:

8502

8962

Product: 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

Lot: 168032

Lot Numbers:

168032

Product: 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

Lot: 169924

Lot Numbers:

169924

Product: 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

Lot: 9002

Lot Numbers:

9002

Product: 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

Lot: 8990

Lot Numbers:

8990

Lot: 8942 BUD: 2/19/2017, Lot: 9207 BUD: 4/17/2017

Lot Numbers:

8942

9207

Lot: 9006 BUD: 1/20/2017, Lot: 8757 BUD: 11/30/2016, Lot: 8954 BUD: 1/6/2017, Lot: 9174 BUD: 2/20/2017

Lot Numbers:

9006

8757

8954

9174

Lot: 9220

Lot Numbers:

9220

Lot: 167081

Lot Numbers:

167081

Product: 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

Lot: 8742

Lot Numbers:

8742

Product: 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

Lot: 9016 BUD: 3/7/2017

Lot Numbers:

9016

Lot: 163941

Lot Numbers:

163941

Product: Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207

Lot: 165538

Lot Numbers:

165538

Lot: 169619

Lot Numbers:

169619

Product: 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

Lot: 8625

Lot Numbers:

8625

Lot: 8997 BUD: 12/1/2016, Lot: 9246 BUD: 1/23/2017

Lot Numbers:

8997

9246

Lot: 9210

Lot Numbers:

9210

Lot: 8995

Lot Numbers:

8995

Product: 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

Lot: 169064

Lot Numbers:

169064

Lot: 169262 BUD: 1/8/2017, Lot: 169812 BUD: 1/19/2017

Lot Numbers:

169262

169812

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75745

Status: Resolved

Manufacturer: Cantrell Drug Company

Manufactured In: United States