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