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The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying Healthcare providers and the public on the distribution and sale of falsified Lantus Solostar Solution for Injection in Prefilled Pens 100 I.U discovered in Lagos Island and reported by Sanofi. The product is referred to as LAN-NI 0011.
Laboratory analysis of the product LAN-NI 0011 was conducted at the company’s anti-counterfeit labouratory in Tours France confirmed that the product is falsified.
Product details of the counterfeit LAN-NI 0011 is as follows;
Product Name: Lantus Solostar Solution for Injection in Prefilled Pens 100 I.U
Batch No.: 1F7647A
Expiry date: December 2023
LAN-NI 0011 is identified as a diverted product originally intended for Turkey market. The box however shows discrepancies when compared to the genuine one. The discrepancies observed are as follows:
- Usually, 2 datamatrix on box used for LANTUS presentation for Turkey market: 1 datamatrix with information batch number and expiry date printed by manufacturer SANOFI Frankfurt and another datamatrix with serialization printed by SANOFI Turkey (Tuzla distribution center) but for case LAN-N1 0011 the datamatrix with serialization is not printed on box but on a sticker glued on a box. Tuzla have never used such material.
- Serial number on additional sticker belongs to SANOFI TURKEY but not related to batch 1F7627A, it was registered in November 2020 to a batch 0F7326A with EXP 07/2023.
- Some impurities have also been detected in the solution which may be due to inappropriate storage conditions.
Lantus Solostar solution for injection is used in the treatment of diabetes mellitus. It maintains the insulin level in the body and helps in controlling the blood sugar level. It helps the blood sugar to get into the cells so that body can use it as energy for various activities. Lantus Solostar solution for injection contains insulin.
The sale and use of the counterfeit Lantus Solostar solution for injection poses a risk to patient health and safety.
NAFDAC advice wholesalers, distributors, pharmacies and consumers to ensure that products are obtained from authentic and reliable sources. Increased vigilance is hereby encouraged within the supply chain to avoid infiltration of the counterfeit Lantus Solostar solution for injection and to prevent the administration of the product to unsuspecting patient by healthcare providers. The products’ authenticity and physical condition should be carefully checked.
Anybody in possession of the counterfeit product should immediately discontinue sale or use and submit stock to the nearest NAFDAC office.
Healthcare providers and consumers are encouraged to report any suspicion of counterfeit drug product to NAFDAC on 0800-162-3322 or email: sf.alert@nafdac.gov.ng, report adverse events experienced with the use of the counterfeit product to the nearest NAFDAC office, via pharmacovigilance@nafdac.gov.ng, E-reporting platforms available at www.nafdac.gov.ng or via the Med- safety application for download on android and IOS stores.
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
