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
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.
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|
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 firstname.lastname@example.org, E- reporting platforms available on the
NAFDAC website or via the Med- safety application available for download on android and IOS stores.