Safety
Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance
For Immediate Release
November 18, 2016
Contact
Consumers
Cantrell Drug Company877-666-5222
Announcement
Little Rock, AK - Cantrell Drug Company is voluntarily recalling
certain unexpired sterile drug products due to lack of sterility
assurance.
The recalled products, distributed nationwide to health care facilities from May 25 to October 31, 2016, are the following:
Administration of a drug product intended to be sterile that is not
sterile could result in serious infections that may be
life-threatening. The company has not received any reports of adverse
events, but is issuing this recall out of an abundance of caution
following a recent inspection of the company’s facility.
Cantrell Drug Company will begin notifying its customers by email and phone and is arranging for the return of all recalled products. Consumers who have product subject to the recall should stop using it and contact the company.
“Because patient safety is our top priority, we immediately began addressing the issues raised and are working closely with health officials,” said Dell McCarley, Chairman & CEO of Cantrell Drug Company. “We have received no reports of injury or illness, and it’s important to note that all of our sterile products are tested for sterility before they are shipped. We deeply regret the impact this voluntary recall has on providers and patients, but our culture is one of safety first and we take absolutely no chances.”
To return medication or request assistance related to this recall, contact Cantrell Drug Company at 877-666-5222, Monday through Friday between 9 a.m. and 5 p.m. CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
The recalled products, distributed nationwide to health care facilities from May 25 to October 31, 2016, are the following:
| Drug Product Name | NDC | Lot Number | Manufacture Date | Beyond Use Date |
|---|---|---|---|---|
| CALCIUM CHLORIDE 1 G ADDED TO 5% DEXTROSE 50 ML BAG | 52533-175-37 | 169170 | 10/15/2016 | 1/5/2017 |
| CALCIUM CHLORIDE 10 G IN 0.9% SODIUM CHLORIDE 500 ML BAG | 52533-102-09 | 168032 | 9/12/2016 | 12/11/2016 |
| CALCIUM CHLORIDE 10% INJECTION SOLUTION 10 ML VIAL | n/a | 169924 | 10/26/2016 | 4/15/2017 |
| FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 150 ML BAG | 52533-024-35 | 9002 | 9/6/2016 | 3/5/2017 |
| FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 250 ML BAG | 52533-024-61 | 8990 | 8/31/2016 | 2/27/2017 |
| FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG
|
52533-080-75 | 8942 | 8/23/2016 | 2/19/2017 |
| FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 250 ML BAG | 52533-080-61 | 9029 | 9/12/2016 | 3/11/2017 |
| FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG | 52533-080-75 | 9207 | 10/19/2016 | 04/17/2017 |
| GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-028-15 | 9006 | 9/7/2016 | 1/20/2017 |
| GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-028-15 | 8757 | 7/18/2016 | 11/30/2016 |
| GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-028-15 | 8954 | 8/24/2016 | 1/6/2017 |
| GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-028-15 | 9174 | 10/11/2016 | 2/20/2017 |
| HEPARIN SODIUM 0.5 USP UNITS/ML IN 0.45% SODIUM CHLORIDE 2 ML SYRINGE | 52533-148-16 | 9220 | 10/20/2016 | 4/18/2017 |
| HEPARIN SODIUM 5,000 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 1,000 ML BAG | 52533-097-24 | 167081 | 8/18/2016 | 2/14/2017 |
| HYDROMORPHONE HCL 0.2 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML SYRINGE | 52533-002-03 | 8742 | 7/13/2016 | 1/9/2017 |
| HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML PCA VIAL | 52533-006-10 | 163941 | 6/21/2016 | 11/30/2016 |
| HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE | 52533-006-04 | 9016 | 9/9/2016 | 3/7/2017 |
| LIDOCAINE HCL 1% INJECTION SOLUTION 10 ML SYRINGE | n/a | 165538 | 7/19/2016 | 1/8/2017 |
| MIDAZOLAM HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE | 52533-001-04 | 169619 | 10/20/2016 | 2/7/2017 |
| MORPHINE SULFATE 1 MG/ML IN 0.9% SODIUM CHLORIDE 100 ML BAG | 52533-160-75 | 8625 | 6/18/2016 | 12/15/2016 |
| NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-046-15 | 8997 | 9/2/2016 | 12/1/2016 |
| NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-046-15 | 9246 | 10/26/2016 | 1/23/2017 |
| OXYTOCIN 30 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 500 ML BAG | 52533-056-30 | 9210 | 10/19/2016 | 1/17/2017 |
| PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE | 52533-171-12 | 8502 | 5/25/2016 | 11/21/2016 |
| PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE | 52533-171-12 | 8962 | 8/25/2016 | 2/21/2017 |
| ROCURONIUM BROMIDE 10 MG/ML INJECTION SOLUTION 5 ML SYRINGE | 52533-064-15 | 8995 | 9/1/2016 | 2/28/2017 |
| ROPIVACAINE HCL 0.25% IN 0.9% SODIUM CHLORIDE 100 ML BAG | 52533-185-75 | 169064 | 10/20/2016 | 1/2/2017 |
| SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE | 52533-067-12 | 169262 | 10/11/2016 | 1/8/2017 |
| SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE | 52533-067-12 | 169812 | 10/24/2016 | 1/19/2017 |
Cantrell Drug Company will begin notifying its customers by email and phone and is arranging for the return of all recalled products. Consumers who have product subject to the recall should stop using it and contact the company.
“Because patient safety is our top priority, we immediately began addressing the issues raised and are working closely with health officials,” said Dell McCarley, Chairman & CEO of Cantrell Drug Company. “We have received no reports of injury or illness, and it’s important to note that all of our sterile products are tested for sterility before they are shipped. We deeply regret the impact this voluntary recall has on providers and patients, but our culture is one of safety first and we take absolutely no chances.”
To return medication or request assistance related to this recall, contact Cantrell Drug Company at 877-666-5222, Monday through Friday between 9 a.m. and 5 p.m. CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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Page Last Updated: 11/21/2016
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