The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the sale of falsified and unregistered brands of Oxytocin Injection in Nigeria.
These products were discovered during the Risk-Based Post Marketing Surveillance (RBPMS) activities carried out by the Post Marketing Surveillance Directorate of the Agency.
Initial Physical screening revealed that the products were in gross violation of labeling requirements. The approved recommended storage temperature of the products is between 2℃ to 8℃, but instead, a storage temperature of below 25℃ was stated on the products.
Oxytocin injection is an injectable drug used for inducing labor, controlling bleeding after childbirth, and for the treatment of incomplete or inevitable abortion.
Risk Statement
The illegal marketing of unregistered medicines or falsified drug products poses a great risk to public health. By not complying with the recommended storage temperature for temperature-sensitive products during importation, distribution, or sale, the safety, quality, and efficacy of the products are not guaranteed.
The administration of falsified or unregistered oxytocin injection products may cause harm to patients or lead to fatal consequences such as death.
Product Details
The details of the falsified and substandard products are as follows:
| S/N | Brand of Oxytocin Injection | APPLICANTS & ADDRESS | MANUFACTURER | REMARKS |
| 1 | A-TOCIN Injection (Oxytocin injection) 10IU/ml
NRN: B4-2006 | Acme Health Care Ltd
3, Church Close, Lakowe Phase 2, Lekki- Epe Expressway, Lakowe, Lagos State | Healthcare Pharma
No address | Store in a cool and dry place, below 250 c
falsified oxytocin injection not registered by NAFDAC but with the same NAFDAC Registration Number (B4-2006) of a product (Cimapro-500 tablets) already registered by the same company. |
| 2 | DERM Oxytocin injection 10 IU/ML (I.M./I.V.)
NRN: C4- 2001 | Derm Pharmaceuticals Ltd, 19 Alhaji Salami Street, Aguda Surulere, Lagos, Nigeria | Shandong Shenglu Pharmaceutical, North of Sihe Road, Sihe Street, Sishui County, Shandong.
| Store in a cool and dry place, below 250 c |
| 3 | PITONS Oxytocin injection 10IU/ML
IM/IV NRN: A4-5928 | Odesco Interlink Nig Limited, 24 Uga Street Fegge Onitsha Anambra, Nigeria. | Shanxi Shuguang Pharm. Co. Ltd No. 1, Kangle St., Q1 County, Jianzhong, Shanxi, China | Store in a cool and dry place, below 250 c |
| 4 | SANO Oxytocin injection 10IU/1ml
For: I.M./I.V. injection NRN: B4-8704 | Enel Pharmaceutical Ltd , No. 45 Ibrahim Street, Sabon Gari, Kano, Nigeria | Sano Pharmaceutical (Qingdao) Co. Ltd 47 Jinkou Road, Lifang District, Qingdao City, Shandong Province, China.
| Store in a cool and dry place, below 250 c
This product is unregistered. The NAFDAC Registration Number B4-8704 does not exist.
|
| 5 | ZYTOCIN Oxytocin injection I.M./I.V.
10IU/1ml NRN: 04-9656 | Chupet Pharm. Co. Ltd, 28 Taorot Street, Surulere, Lagos, Lagos State, Nigeria.
| Tianjin King York Group Hubei Tianyao Pharma. Co. Ltd No. 99, Hanjiang Bei Road, Xianyang, Hubei, China.
| Store in a dark and dry place, below 200c
|
| 6 | CLAXITODIN Injection (Oxytocin 10IU/ml for IM/IV injection
NRN:04- 9566 | Anhui Hongye, Pharmaceutical Co. Ltd. Feng Yang East Road 76, Bengbu, Anhui Province, China.
| Store in a cool, dry, and dark place
This product is unregistered. The NAFDAC Registration Number 04- 9566 does not exist
|
These products have been distributed to several parts of the country through legal and illegal channels and it is important to detect and remove them from circulation to prevent harm to patients. Consequently, NAFDAC has directed all State offices to conduct surveillance and mop up all violating batches of these products.
NAFDAC implores importers, distributors, retailers, and healthcare providers to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, or use of falsified or unregistered medicinal products. All medicinal products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above-mentioned product are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have these falsified or unregistered products, please DO NOT use them. If you, or someone you know, have used the product or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines 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 the medicinal product 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
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
