Recalls & Alerts Published by NAFDAC

The attention of the Agency has been drawn to the recall of one Lot of GNC Women’s Ultra Mega Time Release Dietary Supplement sold in 180 count containers due to the fact that the product may contain undeclared major food allergen- milk. People who have an allergy or severe sensitivity to milk run the risk of a serious life threatening allergic reaction if they consume this product.

The affected product is packaged in a HDPE plastic bottle with a child resistant closure and has Lot number 3044FQ2024 and expiration date of June 2018. The lot number is found on the bottom of the product box and the side panel of the product label.

Adverse events associated with the use of this product should be reported to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC………Safeguarding the Health of the Nation!!!

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.

 

NAFDAC..........Safeguarding the health of the nation!!!

The attention of the Agency has been drawn to the South Korea Ministry of Food and Drug Safety (MFDS) resolution to maintain approval for the sale of Contentious lung cancer treatment medication called Olmutinib sold under the Trade Name Olita Tab.

Olmutinib, also known as HM61713 or BI14829 a third-generation lung cancer therapy has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI).

It has been a breakthrough therapy for patients who have developed a tolerance to existing lung cancer treatments. The ministry however, stressed that Healthcare providers should receive consent form from patients before using the drug, in order to provide a treatment opportunity for patients who have no alternative treatment.

INFORMATION ON PRODUCT

  • Manufacturer: Hanmi Pharmaceuticals Company, South Korea.
  • Drug name: Olmutinib sold under the trade name Olita Tab.

In view of this, the:

Patients taking Olmutinib should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.

Healthcare professionals are implored to report adverse effect or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

 

NAFDAC.........Safeguarding the health of the nation!!!

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