Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance

News provided by

Ball Consulting Group, LLC

Nov 18, 2016, 16:00 ET

Little Rock, Ark. (PRWEB) November 18, 2016 -- 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:

• CALCIUM CHLORIDE 1 G ADDED TO 5% DEXTROSE 50 ML BAG -- NDC 52533-175-37, Lot # 169170, Manufacture Date (MD) 10/15/2016, Beyond Use Date (BUD) 1/5/2017
• CALCIUM CHLORIDE 10 G IN 0.9% SODIUM CHLORIDE 500 ML BAG -- NDC 52533-102-09, Lot # 168032, MD 9/12/2016, BUD 12/11/2016
• CALCIUM CHLORIDE 10% INJECTION SOLUTION 10 ML VIAL -- NDC n/a, Lot # 169924, MD 10/26/2016, BUD 4/15/2017
• FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 150 ML BAG -- NDC 52533-024-35, Lot # 9002, MD 9/6/2016, BUD 3/5/2017
• FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 250 ML BAG -- NDC 52533-024-61, Lot # 8990, MD 8/31/2016, BUD 2/27/2017
• FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG -- NDC 52533-080-75, Lot # 8942, MD 8/23/2016, BUD 2/19/2017
• FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 250 ML BAG -- NDC 52533-080-61, Lot # 9029, MD 9/12/2016, BUD 3/11/2017
• FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG -- NDC 52533-080-75, Lot # 9207, MD 10/19/2016, BUD 4/17/2017
• GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-028-15, Lot # 9006, MD 9/7/2016, BUD 1/20/2017
• GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-028-15, Lot # 8757, MD 7/18/2016, BUD 11/30/2016
• GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-028-15, Lot # 8954, MD 8/24/2016, BUD 1/6/2017
• GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-028-15, Lot # 9174, MD 10/11/2016, BUD 2/20/2017
• HEPARIN SODIUM 0.5 USP UNITS/ML IN 0.45% SODIUM CHLORIDE 2 ML SYRINGE -- NDC 52533-148-16, Lot # 9220, MD 10/20/2016, BUD 4/18/2017
• HEPARIN SODIUM 5,000 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 1,000 ML BAG -- NDC 52533-097-24, Lot # 167081, MD 8/18/2016, BUD 2/14/2017
• HYDROMORPHONE HCL 0.2 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML SYRINGE -- NDC 52533-002-03, Lot # 8742, MD 7/13/2016, BUD 1/9/2017
• HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML PCA VIAL -- NDC 52533-006-10, Lot # 163941, MD 6/21/2016, BUD 11/30/2016
• HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE -- NDC 52533-006-04, Lot # 9016, MD 9/9/2016, BUD 3/7/2017
• LIDOCAINE HCL 1% INJECTION SOLUTION 10 ML SYRINGE -- NDC n/a, Lot # 165538, MD 7/19/2016, BUD 1/8/2017
• MIDAZOLAM HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE -- NDC 52533-001-04, Lot # 169619, MD 10/20/2016, BUD 2/7/2017
• MORPHINE SULFATE 1 MG/ML IN 0.9% SODIUM CHLORIDE 100 ML BAG -- NDC 52533-160-75, Lot # 8625, MD 6/18/2016, BUD 12/15/2016
• NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-046-15, Lot # 8997, MD 9/2/2016, BUD 12/1/2016
• NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-046-15, Lot # 9246, MD 10/26/2016, BUD 1/23/2017
• OXYTOCIN 30 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 500 ML BAG -- NDC 52533-056-30, Lot # 9210, MD 10/19/2016, BUD 1/17/2017
• PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE -- NDC 52533-171-12, Lot # 8502, MD 5/25/2016, BUD 11/21/2016
• PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE -- NDC 52533-171-12, Lot # 8962, MD 8/25/2016, BUD 2/21/2017
• ROCURONIUM BROMIDE 10 MG/ML INJECTION SOLUTION 5 ML SYRINGE -- NDC 52533-064-15, Lot # 8995, MD, 9/1/2016, BUD 2/28/2017
• ROPIVACAINE HCL 0.25% IN 0.9% SODIUM CHLORIDE 100 ML BAG -- NDC 52533-185-75, Lot # 169064, MD 10/20/2016, BUD 1/2/2017
• SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE -- NDC 52533-067-12, Lot # 169262, MD 10/11/2016, BUD 1/8/2017
• SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE -- NDC 52533-067-12, Lot # 169812, MD 10/24/2016, BUD 1/19/2017

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.
• Online: http://www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form http://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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Greg Turner, for Cantrell Drug Company, Ball Consulting Group, LLC, +1 617-243-9950, [email protected]