Cancellation of registration

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Medicine

 Nature of the Quality Failure  
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to the Assay test.

 

Name of the product ; Chloramphenicol capsules BP 250 mg

Manufacturer: Centurion Remedies (Pvt) Ltd, India
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to labeling. 

 

Name of the product : Chloramphenicol Ear drop BP 5% w/v

Brand name: Chlorowin

Manufacturer: Belco Pharma, India
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to Uniformity of weight.

 

Name of the product: Phenytoin Tablets BP 25 mg

Manufacturer: Mercury Laboratories Ltd, India
 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to Salicylic acid test.

 

Name of the product: Aspirin tablets BP 300 mg

Manufacturer: Mercury Laboratories Ltd, India

Cancelation of registration certificate and Import license due to failure of registration sample to comply with USP specification with respect to particulate matter test.

 

Name of the product: Ceftazidime for Injection USP 500 mg

Manufacturer: Injectcare Parenterals (Pvt) Ltd, India

 

Cancelation of registration certificate and Import license due to failure of registration sample to comply with BP specification with respect to the Acidity test.

 

Name of the product: Suxamethonium Chloride Injection BP 100mg/2ml

Manufacturer: Swiss Parenterals (Pvt) Ltd, India

 

 

Recall of batch due to a quality defect.

 

Name of the product: Bisoprolol fumarate tablets USP 5mg

Brand name: BRISOTOL 5

Manufacturer: Fredun Pharmaceuticals Ltd, India

Batch No: FG9016

Failure/Defect: Some boxes/sealed packs contain less number of tablets than stated on the label of the outer carton.

 

 

Borderline Products

 Nature of the Quality Failure  

 Any available btches in the market to be withdrawn based on the recall notice published by the TGA, Australia

 

Name of the product: Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish oil, Pastilles (Soft Gummies) 60's

Manufactuer: Pharmacare Laboratories Pty Ltd, Australia

 

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    Cosmetics

     Nature of the Quality Failure  

     Hand sanitizers found to be substandard

     Recall of batch due to a Quality defect

     

    Name of the product: Rub in Hand Disinfectant (STERIMED) 

    Manufacturer: Medicom, Sri Lanka

    Batch No: SM01A20

    Failure/Defect: 1) Presence of a dead cockroach inside on bottle.

                          2) Pump bottles are not tamper-evident. Plastic wrapper seal is limited only to cap with squeezing tip 

     

     

    Details