Powered by ZigaForm version
(Last Updated On: December 31, 2020)

Recall of Sodiofolin 50 mg/ml Solution for Injection by Medac Pharma LLP due to Some Inspected Vials Showing Hairline Damage to the Shoulder of the Vials

December 30, 2020,

The National Agency for Food and Drug Administration and Control has been informed by the U.K. Medicines and Healthcare Regulatory Agency (MHRA) that Medac Pharma LLP has recalled   Sodiofolin 50 mg/ml Solution for Injection with expiry date 28/02/2022 due to some inspected vials showing hairline damage to the shoulder of the vials.

Sodiofolin 50 mg/ml Solution for Injection is used for the prevention of possible side effects          resulting from methotrexate therapy or for treatment of cancer in combination therapy
with 5-fluorouracil.

So far, the company has not received any reports of damage for marketed products. However, as this defect may impact on the sterility of the product, the above batch is being recalled as a precautionary measure.

Product Details

The details of the recalled lot of Regenecare HA Hydrogel are as follows;

Product Name: Sodiofolin 50 mg/ml Solution for Injection
Product Manufacturer: Medac GmbH T/A medac Pharma LLP
Active Ingredient: Disodium Folinate
Expiry Date 28/02/2022
Batch Number B190132C

Healthcare providers Action

Healthcare professionals are encouraged to:

  • Stop dispensing or distributing Sodiofolin 50 mg/ml Solution for Injection with expiry date 28/02/2022 and remove from the shelves within your store.
  • Return unused products to the nearest NAFDAC office for regulatory action

Healthcare providers and patients are encouraged to report adverse events experienced with the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks),  via pharmacovigilance@nafdac.gov.ng, E- reporting platforms available on the

NAFDAC website or via the Med- safety application available for download on android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

Was this post helpful?