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Products Recalled in 2024

S/N

 

Date recall was initiated

Recall Reference Number

Product Name/ Category

INN Name (s)

Batch Number (s)

Name of Manufacturer

Reasons for recall

Status

19.

15/08/2024

REC/2024/019

S-Prazo

Esomeprazole 40mg

SPZ-302

Laborate Pharmaceutical India Limited

Mix-up with Donystatin Tablets blisters within some secondary packs

Ongoing

18.

01/08/2024

REC/2024/018

Efinox 1% Nasal Drops

Ephedrine Hydrochloride

82979

Laboratory & Allied Ltd, Kenya

OOS results on Assay

Ongoing

17.

01/08/2024

REC/2024/017

Doximar Capsules

Doxycycline

100mg

BPL 281A

Biopharma Ltd, Kenya

OOS results on Assay, Dissolution and Weight Variation

Ongoing

16.

25/07/2024

REC/2024/016

Medimol Suspension

Paracetamol

120mg/5ml

M13016

Medivet Products Ltd, Kenya

OOS results on Assay

Ongoing

15.

08/07/2024

REC/2024/015

Lidocel Injection

Lidocaine & Adrenaline

762206

Systochem Laboratories Ltd, India

Color change to brown

Ongoing

14.

17/07/2024

REC/2024/014

Painil Suspension

Paracetamol 120mg/5ml

59014, 59114, 59314, 59414

Njimia (K) Ltd, Kenya

Color change from Pink to brown

Ongoing

13.

06/06/2024

REC/2024/013

Caryl Expectorant

Salbutamol, Bromhexine & Guaiphenesin

1022035

Biodeal Ltd,

Kenya

OOS results on Assay

Ongoing

12.

15/05/2024

REC/2024/012

AmoxiClav-Denk 1000/125mg powder for oral suspension

Amoxicillin + Clavulanic Acid

27608

Denk Pharma GmbH & Co KG, Germany

Visual changes in appearance detected in an ongoing stability study

Ongoing

11.

23/04/2024

REC/2024/011

Curamol Suspension

Paracetamol

120mg/5ml

2211230

Dawa Life Sciences Ltd, Kenya

Crystallization

Closed

10.

11/04/2024

REC/2024/010

Benylin Pediatric 100 ml Cough Syrup

Diphenhydramine HCL

329304

Johnson & Johnson (Pty), South Africa

Safety concerns due to unacceptable high levels of Diethylene glycol

Closed

9.

27/03/2024

REC/2024/009

DTS-Z (Dehydration treatment salts)

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

230179, 230182

Cosmos Limited, Kenya

Failure in description- change in colour

Closed

8.

25/03/2024

REC/2024/008

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 Ltd, India.

Formation of black spots in the suspension

Ongoing

7.

25/03/2024

REC/2024/007

Azithrosafe Suspension

Azithromycin 200mg/5ml

GE04139

Enicar Pharmaceuticals Pvt Ltd, India

Formation of black spots in the suspension

Ongoing

6.

22/03/2024

REC/2024/006

Haemaccel 500ml Injection

Polygeline

HA3004

Piramal Pharma Limited, India

Bottle leakages and damage to mono
cartons

Closed

5.

13/03/2024

REC/2024/005

Izzithree Suspension

Azithromycin

BPL 149A, BPL 068A, BPL 227A

Biopharma Ltd,

Kenya

Less than the required fill volume

Ongoing

4.

08/02/2024

REC/2024/004

Amitrip Tablets

Amitriptyline

25mg

81647

Laboratory & Allied Ltd, Kenya

Capping/Lamination of the tablets

Ongoing

3.

08/02/2024

REC/2024/003

Chlorpromazine Tablets

Chlorpromazine

100mg

82172, 82173

82174,79887

Laboratory & Allied Ltd, Kenya

Capping/Lamination of the tablets

Ongoing

2.

22/01/2024

REC/2024/002

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

Closed

1.

20/01/2024

REC/2024/001

Diarim Aqueous cream B.P

Aqueous cream

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

Diarim Enterprises Limited, Kenya

Presence of molds

Ongoing