The recall of the batch 41016Α-2 with an expiration date 4/2017 of the medicinal product Cosmofer,, solution for injection or infusion 50 mg/ml ampoules, proceeded to the National Organisation for Medicines (EOF), then from information of the company Pharmacosmos A/S that it intends to proceed to a recall due to a potential quality problem in this particular batch.
As noted by the FDA, this decision is issued in the context of the protection of public health, with a view to enhance the voluntary recall by the company Pharmacosmos A/S in cooperation with the company DEMO SA. The last, according to the FDA, is charged with the responsibility of direct communication with customers, for the realization and successful completion of the withdrawal of this formulation from the market.
Source: ana – MPA
Withdrawal of ordinary drug by the FDA
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