The National Agency for Food and Drug Administration and Control (NAFDAC) is warning healthcare providers, patients, and the public about the falsification and parallel importation of three batches of a NAFDAC-registered product: Dostinex 0.5mg Tablets.
Pfizer Nigeria Ltd, the Marketing Authorization Holder (MAH) of the products, has confirmed the presence of falsified and parallel unregistered imported versions of these products. According to Pfizer Nigeria Ltd, the legitimate product has been registered but has not yet been imported into Nigeria.
Dostinex 0.5 mg is a medication that reduces prolactin secretion, helping to alleviate symptoms caused by excess prolactin.
Risk Statement
The potency of products is highly dependent on complying with regulatory requirements. Falsified, unlicensed, and unregistered medicines present significant risks to public health because these products have not been evaluated by NAFDAC. Therefore, the quality, safety, and efficacy of these products cannot be guaranteed.
Product Details
Product Name | Dostinex 0.5mg Tablet |
Batch Numbers | GG3470, LG8659, and GG2440, respectively |
Expiry dates | June 2027, Jan. 2026, and April 2026, respectively |
NAFDAC Reg. No. | Nil |
Product Manufacturer | Pfizer Italia S.R.L, Ascoli Piceno, Italy. |
NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines circulating in Nigeria.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the unregistered products if found within the zones and states.
Distributors, retailers, healthcare professionals, and caregivers are hereby advised to note the discrepancies stated above, exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of the unregistered products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals are advised to review stocks within hospitals, clinics, and pharmacy stores, report any suspected falsified or compromised products (medicines or medical devices) to the nearest NAFDAC office, 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
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
