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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

31.

18/11/2024

REC/2024/032

Pharmasal Spray

 

2-Hydroxyethyl salicylate, Ethyl salicylate, Methyl nicotinate, Methyl salicylate

4001, 4002, 4003, 4004, 4005

Qingyuan Latop Fine Chemicals Limited, China

Leakage of the product from the cans

Ongoing

30.

12/11/2024

REC/2024/031

Paratal Tablets

Paracetamol

83835, 83854 and 83855

Laboratory and Allied Limited, Kenya

Dark brown spots on the tablet

Ongoing

29.

07/11/2024

REC/2024/030

Nurabucaine Injection

Bupivacaine HCl in Dextrose

ADA22002

Farbe Firma, India

Out of Specification (OOS) results on assay for dextrose

Ongoing

28.

22/10/2024

REC/2024/029

Sigmaflex

Latex Examination Gloves (Powdered)

20231012

A1 Globe Sdn. Bhd., Malaysia

Out of Specification (OOS) results on water tightness test

Ongoing

27.

22/10/2024

REC/2024/028

Phenysod Injection

Phenytoin

H24119

Hiral Laboratories Ltd, India

Formation of a precipitate when mixed with normal saline for infusion.

Ongoing

26.

22/10/2024

REC/2024/027

Tricohist Expectorant

Diphenhydramine HCl BP 5mg, Promethazine HCl BP 2.5mg, Ephedrine HCl BP 7.5mg, Ammonium Chloride BP 90mg and Sodium Citrate BP 45mg

0723040

Biodeal Laboratories Ltd, Kenya

OOS results on assay of Diphenhydramine HCl and Promethazine HCl

Ongoing

25.

14/10/2024

REC/2024/026

Painil Suspension

Paracetamol 120mg/5ml

58914, 59514, 59614, 59714

Njimia (K) Ltd, Kenya

Color change from pink to brown

Ongoing

24.

26/09/2024

REC/2024/025

Flamodip Tablets

Amlodipine 5mg

FLD303

Medico Remedies Pvt Ltd, India

Mislabeling. The secondary package is labelled as Flamodip-5 (Amlodipine), while the primary package is labelled as Flaminopril-5 (Enalapril)

Ongoing

23.

17/09/2024

REC/2024/023

Carvedi-Denk

Carvedilol 25mg

27374

Artesan Pharma GmbH & Co. KG

  OOS results on dissolution

Ongoing

22.

09/09/2024

REC/2024/022

Neuropower Forte

Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Nicotinamide, Calcium Pantothenate

299, 300

Hof Pharmaceuticals Ltd, India

Powdering/crumbling of the tablets

Ongoing

21.

15/08/2024

REC/2024/021

S-Prazo

Esomeprazole 40mg

SPZ-302

Medico Remedies Limited, India

Mix-up with Donystatin Tablets blisters within some secondary packs

Ongoing

20.

14/08/2024

REC/2024/020

Rabemac

Rabeprozole 20mg

ERW2203A, ERW23001C

Macleods Pharmaceuticals Limited, India

OOS results on assay

Ongoing

19.

01/08/2024

REC/2024/019

Efinox 1% Nasal Drops

Ephedrine Hydrochloride

82979

Laboratory & Allied Ltd, Kenya

OOS results on Assay

Ongoing

18.

01/08/2024

REC/2024/018

Doximar Capsules

Doxycycline

100mg

BPL 281A

Biopharma Ltd, Kenya

OOS results on Assay, Dissolution and Weight Variation

Ongoing

17.

25/07/2024

REC/2024/017

Medimol Suspension

Paracetamol

120mg/5ml

M13016

Medivet Products Ltd, Kenya

OOS results on Assay

Ongoing

16.

18/07/2024

REC/2024/016

Atravita Injection

Atracurium Besylate BP 10mg

V21153

Vital Healthcare Pvt Limited, India

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

Closed

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

Closed

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

Closed

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

Closed

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

Closed

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