Our Ref: MDR 01-02/17
Drug Name: Propofol Emulsion for Injection 1%w/v
Brand Name: Please refer to Table 1below:
Norbrook Laboratories Ltd is voluntarily recalling the product Propofol Emulsion for Injection 1.0%w/v and all brand names listed below as a precautionary measure. Norbrook has verified that an issue of coring, i.e. the shearing off of a portion of the 20mm bromobutyl bung, as the vial is pierced to withdraw finished product has been observed in a small number of vials. This may result in particles from the bung entering the product and potentially being drawn up into the syringe upon extraction of the product from the vial. It may also result in the bung not resealing fully after use. Norbrook thus request your action within forty eight hours (48} of receipt of this letter. Your company is requested to immediately quarantine any remaining stock within your inventory. Only the products listed below are affected by this notice.
In consultation with the Veterinary Medicines Directorate, we request that all remaining vials of the products listed below be returned to your wholesale distributor. Please check your remaining stock to determine whether you have any of the specified products indicated below. If yes, as previously requested, ensure you quarantine all vials of this product and contact your wholesale distributor.
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