The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare professionals, importers, distributors, retailers, and the public that the Drug Regulatory Authority of Pakistan (DRAP) has recalled specific batches of adulterated and substandard medicines (Nitras, Kadin 2, Acefyl and Loratadine 24) due to quality defects, contamination concerns, and failure to meet regulatory quality standards.
Risk Statemen
The use of adulterated or substandard medicines may result in reduced therapeutic efficacy, unexpected adverse reactions, treatment failure, and serious health consequences. Patients using these medicines for cardiac conditions, allergies, muscle spasms, and cough-related illnesses may be at increased risk of complications.
Product Details
The recalled product details are as follows.
Product Name | Active Ingredient | Batch No. | Manufacturer | Regulatory Finding |
Tablet Nitras | Glyceryl Trinitrate | 24L069 | M/s Caraway Pharma, Rawat | Substandard |
Tablet Kadin 2 | Tizanidine Hydrochloride | 569 | M/s FYNK Pharma, Lahore | Adulterated |
ACEFYL Cough Syrup | Acefylline Piperazine | ACH479 | M/s NABIQASIM Industries, Karachi | Adulterated |
Tablet Loratadine 24 | Loratadine | 24 | M/s Murfy Pharma, Lahore | Adulterated |
Monitoring is ongoing to ensure the recalled products do not gain entrance into Nigeria. All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove the recalled products if found within their zones and states.
NAFDAC advises importers, distributors, healthcare facilities, pharmacies, and the public to be vigilant throughout the supply chain. Avoid procuring or distributing the affected batches if identified.
Healthcare professionals and consumers should avoid buying and using the recalled products. All medical products must be bought from authorized or licensed suppliers. The authenticity and physical condition of the products should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
