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Complaints, Feedback and Enquiry

Rapid Alert – 2023

S/N

DATE

TITLE

PRODUCT TYPE

SOURCE OF RAPID ALERT

MANUFACTURER

10

21st November 2023

Public notice on falsified batches of truvada (emtricitabine/ tenofovir 200mg/300mg) product

Batches B4033894D and B425875D

 

Medicine

PPB

Stated as; manufactured by Gilead Sciences Inc.

 

9

21st November 2023

Warning regarding suspected falsified themra epimedyumlu

Macun (“asali ya wazee”) manufactured by veysi topuz

 

Claimed to be  herbal product

PPB

Stated as manufactured by Veysi Topuz

 

8.

18-Sep-2023

Public Alert on Mandated Recall of Tamedol (Paracetamol) Oral Solution 120mg/5ml. 

Investigations by PPB confirmed that the product failed to meet market authorization requirements.

Medicine

Pharmacy and Poisons Board

Biopharma LTD, Kenya

7.

18-Sep-2023

Public Alert on Substandard and Falsified (SF) Radio Contrast Media – Visipaque (Iodoxanol) 320mg/ml Vials.

 

Batches where manufacturer is stated as GE Healthcare Ireland, 15950809, 15944839, 15950792, 15906117

Batches where manufacturer is stated as GE Healthcare (Shanghai) Co., Ltd, China

15389618, 15429745, 15444386, 15661498, 15904073, 15751274,16017833, 16044911, 16085815, 16100415, 16107210, 16177061

Radio Contrast Media

Pharmacy and Poisons Board

Batches where manufacturer is stated as GE Healthcare Ireland15950809, 15944839, 15950792, 15906117

Batches where manufacturer is stated as GE Healthcare (Shanghai) Co., Ltd, China

15389618, 15429745, 15444386, 15661498, 15904073, 15751274,16017833, 16044911, 16085815, 16100415, 16107210, 16177061

6.

7-Aug-2023

Medical Product Alert on Substandard (contaminated) syrup medicines identified inWHO Region of the Eastern Mediterranean

 

COLD OUT syrup Batch No: SF001A02

The product contains unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Medicine

The World Health Organization

Stated as FOURRTS (INDIA) LABORATORIES PVT. LTD

5.

19-July-2023

Medical Product Alert on Substandard (contaminated) syrup medicines identified inWHO Region of Africa

NATURCOLD Syrup, Batch No: E22053

The product contains unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Medicine

The World Health Organization

Stated as FRAKEN INTERNATIONAL (England)

4.

25-Apr-2023

Medical Product Alert  on Substandard (contaminated) syrup medicines identified inWHO Region of the Western Pacific

GUAIFENESIN SYRUP TG SYRUP, Batch No: SL-429

The product contains unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Medicine

The World Health Organization

Stated as QP PHARMACHEM LTD (Punjab, India).

3.

11-Apr-2023

Medical Product Alert on Falsified DEFITELIO (defibrotide sodium)identified in the WHO Regions of Europe and the Eastern Mediterranean

Batch No: 19G19A identified in Kyrgyzstan and United Arab Emirates

Batch No (packaging): 19G19A, Batch No (vial): M068466E identified in Kyrgyzstan

Laboratory analysis of a sample of the falsified product found that it did not contain any of the stated active ingredient.

Medicine

The World Health Organization

Stated as Gentium Srl

2.

22-Feb-2023

Medical Product Alert on TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%

Batch No: AF20011, AF21160, AF21161, AF22031, AF22032, AF22093, AF22100, AF22101, AF22107, AF20097, AF22021, AF20060A, AF22025, AF22026, AF22061, AF20067, AF21064, AF21088, AF21147, AF21149, AF22006, AF22007, AF22029, AF22030, AF22057, AF22058, AF22080, AF22098, AF22099, AF22104, AF22118, AF22123, AF22106, AF22116, AF22092A, AF22097A, AF22110, AF22111, AF22112, AF22113, AF22114, AF22115, AF22117, AF22119, AF22120, AF22121, AF22122, AF22020A

The product had a range of quality issues e.g., particles ranging in colour, size and shape on the nozzle, in the cap and in the ointment inside each tube,

black spots and brown splotches on the inner foil layer of the tube, and phase separation. These issues were not uniform and varied from batch to batch.

Medicine

The World Health Organization

Stated as Galentic Pharma (India) Pvt. Ltd

1

11-Jan-2023

Medical product alert on substandard (contaminated) liquid dosage medicines identified in Uzbekistan and reported to WHO on 22nd December 2022.

AMBRONOL syrup products 

Batches: (AAS2103 AAS2202 AAS2201 AAS2204)

and

DOK-1 Max syrup products

Batches: DXS2104, P/DXS- H/2101, DXS2105 DXS2106, DXS2107, DXS2108, DXS2109, DXS2201, DXS2202, DXS2203, DXS2205, DXS2206, DXS2207, DXS2208, DXS2209,

DXSH2201,DXSH2202

The products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.

Medicines

The World Health Organization (WHO)

Stated as;

MARION BIOTECH PVT. LTD, (Uttar Pradesh, India)