Thursday, 19 January 2017 15:07

Recall Of Sterile Drug Products by Cantrell Drug Company

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The National Agency for Food and Drug Administration and Control has been notified that Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products. 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.

Reason for recall

These unexpired drug products were recalled due to lack of sterility assurance.

Possible risks

This can result to serious infections that may be life-threatening

 

Affected product details

 

PRODUCT DRUG NAME NDC LOT NUMBER MANUFACTURE NUMBER 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

 

Healthcare provider’s action

Discontinue use of drugs

Report all serious adverse events or side effects related to the use of this drug to NAFDAC PRASCOR(20543-TOLL FREE FROM ALL NETWORK)or via individual case safety report forms or via email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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Read 2835 times Last modified on Thursday, 19 January 2017 15:13

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