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The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying Health care Providers and public that Wockhardt UK Ltd is recalling a batch of Diazepam RecTubes 2.5mg Rectal solution due to an out-specification result for assay during routine stability testing.
Product information
| Brand Name | Batch No | PACK SIZE | Expiry date | Manufacturer |
| Diazepam RecTubes 2.5ml Rectal solution. | 155061 | 5×1.25ml | Jan 2023 | Wockhardt UK Ltd |
Diazepam rectal tubes may be used in acute severe anxiety and agitation, epileptic and febrile convulsions, tetanus, as a sedative in minor surgical and dental procedures, or other circumstances in which a rapid effect is required but where intravenous injection is impracticable or undesirable.
NAFDAC implores all importers, wholesalers, and retailers to immediately stop the importation, distribution, and use of the affected batch of Diazepam RecTubes 2.5mg Rectal solution.
Patients are advised to report adverse events and quality problems they experience with the use of any regulated product to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng
References
https://www.medicines.org.uk/EMC/medicine/12168/
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
