Recalls & Alerts Published by NAFDAC

Dear Healthcare provider,                               

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by united states food and drug administration (FDA) that Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the post marketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Symptoms of anaphylaxis may include wheezing or difficulty in breathing, swelling of the face or throat, hives or flushing, itching,abdominal cramping or vomiting, back pain or chest pain, hypotension or shock.

Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adult in combination with other drugs (antiemetic) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing cancer chemotherapy.

Recommended Action

  • Health care professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
  • It is advised that health care professionals consult with patients to determine if they are hypersensitive to any component of the product including soy beans.
  • Patients with known allergies to legumes or other related allergens should be monitored closely.
  • Patient with known hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.
  • Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.
  • If anaphylaxis or any other serious hypersensitivity /infusion reaction occurs, appropriate medical management should be initiated and Varubi should be permanently discontinued.
  • Healthcare providers and patients are encouraged to report adverse reactions associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR 920543 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

Signed Management

Dear Healthcare provider and Consumers,

The National Agency for Food and Drugs Administration and Control (NAFDAC) has been informed that Kareway Products Inc is recalling 60000 lots of Gericare Eye wash irrigation solution, 4 fluid ounces. The product has been found to have potential microbial contamination which compromises sterility. Use of the affected product could be calamitous for any population due to a potential sight threatening eye infection or impairment.

Gericare Eye wash is used to clean, refresh, sooth eyes for daily use or emergency eye cleansing by flushing foreign material.

Recalled Product Details:

Pack Size: 4 fluid ounce (118 ml) bottles.

Lots Number: #86041601

Expiration date: 09/2019

UPC NO: 3-57896 to 18604-3

Healthcare Provider’s Action

  • Healthcare providers in possession of these affected products should stop using them and submit to nearest NAFDAC office.
  • Consumers should contact their Physician or healthcare providers if they have experience any problems that may be related to taking or using this product.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, 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

Signed Management

The National Agency for Food and Drug Administration and Control has been informed by the United States Food and Drug Administration that it is working with manufacturers of Imodium (loperamide) to use blister packs or other single dose packaging and to limit the number of doses in a package. This is to foster the safe use of the over-the counter (OTC) anti-diarrhea drug loperamide. This is as a result of increased reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label.

Loperamide is FDA-approved to help control symptoms of diarrhea. It acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. Loperamide is a safe drug when used as directed.

Possible Risks

Intake of much higher dose than recommended can lead to serious problems, including severe heart rhythm problems and death.

Consumer/ Healthcare Provider Action

  • Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label.
  • Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events.
  • Healthcare professionals and patients are encouraged to report adverse events 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

Signed Management

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