S/N

Date recall was initiated

Product Name/ Product Category

INN Name (s)

Batch Number(s)

Name of Manufacturer

Reasons for recall

Status

10

11/04/2024

Benylin Pediatric 1oomLs cough syrup

Diphenhydramine HCL

329304

Johnson & Johnson (Pty), South Africa

Safety concerns due to unacceptable high levels of Diethylene glycol

On-going

9

27/03/2024

DTS-Z (Dehydration treatment salts)

Sodium chloride BP, Potassium chloride BP, Trisodium citrate BP and anhydrous glucose BP

230179 and 230182

Cosmos Limited, Kenya

Failure in description- change in colour

On-going

8.

25/03/2024

MZ-CAL PLUS SUSPENSION

Elemental Calcium, Elemental Phosphorus (As milk mineral concentrate), Magnesium Hydroxide BP Equivalent to Elemental Magnesium, Zinc Sulfate Monohydrate USP Equivalent to Elemental Zinc, Vitamin D3 BP

GE-13170

ENICAR PHARMACEUTICALS PVT LIMITED

Color change

On-going

7.

25/03/2024

AZITHROSAFE SUSPENSION

Azithromycin

GE04139

ENICAR PHARMACEUTICALS PVT LTD

Color change of the suspension

On-going

6.

22/03/2024

HAEMACCEL 500ML

Polygeline

HA3004

Piramal Pharma Limited

bottle leakages and damage to mono
cartons

On-going

5.

13/03/2024

IZZITHREE SUSPENSION

Azithromycin

149A, BPL 068A, 227A

BIOPHARMA LTD, Kenya

Less than the required fill volume

On-going

4.

08/02/2024

AMITRIP

Amitriptylline

81647

Laboratory & Allied Ltd, Kenya

Capping/Lamination of the tablets

On-going

3.

08/02/2024

CHLOPROMAZINE

Chlopromazine

82172, 82173,82174,79887

Laboratory & Allied Ltd, Kenya

Capping/Lamination of the tablets

On-going

2.

22/01/2024

Blink Paracetamol

Paracetamol

2211011

Shijiazhuang No.4 Pharmaceutical Ltd, China

Change in color to pale yellow, along with the presence of a white crystalline deposit at the vial neck or seal, suggesting a potential issue with integrity or leakage

On-going

1.

20/01/2024

Diarim Aqueous cream BP

Aqueous cream

44523DAC; 44223DAC; 34423 DAC; 13823DAC, 13223DAC

Diarim Enterprises Limited, Kenya

Presence of mold

On-going