NAFDAC Nigeria: Latest Drug Product Recalls & Safety Alerts

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued public alerts and safety communication affecting the following drug products in the months of November and December 2019.

[NAFDAC Public Alert No: 0022/2019, December 4, 2019] – Alert on Recall of Glosunate® Plus 50 (Artesunate 50mg and Amodiaquine 153mg) Tablets Batch Number GK18010

Reason for the recall: Unsatisfactory report of laboratory analysis. Failed assay, dissolution and related substances tests.

Company Name: Uche St. Company Limited

Manufacturer: Globela Pharma Pvt, Gujarat, India

NAFDAC has taken action to prevent or stop the distribution and sale of Glosunate Plus 50 tablets Batch Number GK18010 in Nigeria. The Agency has also directed all distributors, wholesalers and retailers to submit Glosunate Plus 50 tablets Batch Number GK18010 in their possession to the nearest NAFDAC office.

Source: Public Alert No: 0022/2019 – Alert on Recall of Glosunate Plus 50 Tablets Batch Number GK18010 Due to Unsatisfactory Report of Laboratory Analysis

[NAFDAC Public Alert No: 0021/2019, December 4, 2019] – Alert on Recall of Solartep® (Dihydroartemisinin 40mg/Piperaquine Phosphate 320mg) Tablets Batch Number F17S0826

Reason for the recall: Unsatisfactory report of laboratory analysis. Failed assay and dissolutions tests.

Company Name: Solutions Pharmaceutical Nigeria Limited

Manufacturer: Mingshen Pharmaceutical Factory, China

NAFDAC has taken action to prevent or stop the distribution and sale of Solartep tablets Batch number F17S0826. The Agency has also directed all distributors, wholesalers and retailers are to submit Solartep tablets Batch number F17S0826 in their possession to the nearest NAFDAC office.

Source: Public Alert No: 0021/2019 – Alert on Recall of Solartep Tablets Batch Number F17S0826 Due to Unsatisfactory Report of Laboratory Analysis

[NAFDAC Public Alert No: 0019/2019, November 3, 2019] – Alert on Voluntary Recall of Xalatan® (Latanoprost 0.005%) Eye Drops Lot Numbers W67369 and AK4753

Reason for the recall: Voluntary recall due to detection of confirmed falsified Xalatan® 0.005% w/v Eye Drops 2.5 ml solution with authentic Pfizer Specialties Limited Lot Numbers W67369 and AK4753. The falsified Xalatan® 0.005% w/v Eye Drops 2.5 ml solution was detected following a market survey conducted by Pfizer Global Security on selected Pfizer products exposed to counterfeiting in the Nigerian market.

Company Name: Pfizer Specialties Limited

Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870, Belgium

NAFDAC has taken steps to prevent the distribution and sale of the falsified Xalatan® 0.005% w/v Eye Drops in Nigeria. The Agency has also directed distributors and wholesalers in possession of Xalatan* (Latanoprost 0.005%) Eye Drops Lot Numbers W67369 and AK4753 to immediately stop their distribution and sale.

Source: Public Alert No: 0019/2019 – Alert on Voluntary Recall of Xalatan* Eye Drops Lot Numbers W67369 and AK4753

For further details

Visit NAFDAC Recalls & Safety Alerts webpage: https://www.NAFDAC.gov.ng/Safety-Alerts/