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Products Recalled in 2023

S/N

Recall Date

Recall Ref No.

Product Name

IIN

Batch(es)

Manufaturer

Reason for recall

Status

18.

07/12/2023

REC/2023/018

Nycodeal 30ml

Nystatin 100,000 IU/ML

0523083, 0523084

Biodeal Laboratories Ltd, Kenya

During routine market surveillance activities, an Out Of Specification (OOS) result of 81.7% was observed in the assay test, with the specified limits ranging from 95.0% to 120.0% of the stated amount.

Closed

17.

15/11/2023

REC/2023/017

Lasideal Tablets

Furosemide

0621126

Biodeal Laboratories Ltd, Kenya

Black Spots on the tablets

Closed

16.

15/11/2023

REC/2023/016

Enril 5 Tablets

Enalapril Maleate

KN532

Prism Life Sciences LTD, India

Out Of Specification (OOS) results following routine market surveillance activities

Closed

15.

17/10/2023

REC/2023/015

Beeclav 457mg Suspension

Amoxicillin & Clavulanic acid

SEBPD-0088

Prism Life Sciences LTD, India

Color change to brown after reconstitution

Closed

14.

18/09/2023

REC/2023/014

Rapiclav 312.5 DT

Amoxicillin & Potassium Clavulanate

JTQ012001 JTQ012002 JTQ012003 JTQ012004 JTQ012005 JTQ012006 JTQ012007 JTQ012008 JTQ012009 JTQ012010 JTQ012011 JTQ012012 JTQ012013 JTQ012014 JTQ012015 JTQ012016 JTQ012017 JTQ012018 JTQ012019 JTQ012020

IPCA laboratories, India

Color change of tablets

Closed

13.

18/09/2023

REC/2023/013

Oralex C Mouthwash

Chlorhexedine Gluconate & Benzydamine Hydrochloride

L220077

Curis Lifesciences PVT LTD, India

Out Of Specification (OOS) results following routine market surveillance activities

Closed

12.

18/09/2023

REC/2023/012

Trimoxol Suspension

Cotrimoxazole

2210033

2205033, 2210005, 2201145, 2207184

Dawa life sciences, Kenya

Market Complaints of bitter taste

Closed

11.

18/09/2023

REC/2023/011

Tamedol Suspension

Paracetamol 120mg/5ml

All Batches

Biopharma LTD, Kenya

Failure to meet prescribed market authorization requirements

Closed

10.

21/08/2023

REC/2023/010

Klincord Solution

Chlorhexidine Digluconate 7.1% drops

WS21136

West Coast Pharmaceuticals, India

The assay of the active ingredient in the product may likely drop below the specifications of 95-105% based on stability data

Closed

9.

17/08/2023

REC/2023/009

DTO Tablets

Ofloxacin/Ornidazole

DDBR2201

Coral Lab Ltd, India

Change in color

Closed

8.

15/06/2023

REC/2023/008

Mesporin Injection 

Ceftriaxone 500mg, 1000mg, 2000mg

Z0142, Z0153 ,Z0030, Z0129 Z0086, Z0115, Z0149, Z0057, Z0107

Labestfal Almiro Laboratories S.A., Portugal

Visible particles in reconstituted powder of the product

Ongoing

7.

01/06/2023

REC/2023/007

Denk-Air Junior

Montelukast 4mg

27084

Denk Pharma GmbH & Co. KG,Germany

Out of specification result in ongoing stability study

Closed

6.

8/5/2023

REC/2023/006

Normnil Tablets

Albendazole 400mg

2103104 2012082 2007067 2007098 2006202 2006200

Dawa life sciences, Kenya

The tablets exhibited the following issues: the appearance of mold-like dots, molding, cracking, the presence of brownish dots, and a change in color.

Closed

5.

3/5/2023

REC/2023/005

Fluconazole Tablets

Fluconazole 200mg

5810959, 5810961, 5810962, 5810960, 5811120, 5811121, 5811122, 5811123, 5811124,5811125, 5811182, 5811183, 5811184, 5811185, 5810958, 5810959, 5810316, 5810320, 5810317

Universal Corporation Limited, Kenya

The pink tablets displayed white discoloration, while both the PVC material and unit box exhibited dark stains.

Closed

4.

25/4/2023

REC/2023/004

Dopamac Tablets

Methyldopa

HMX20007A HMX20008A HMX20009A

Macleods pharmaceuticals Ltd

Cracking of tablet coating and dark spots on the tablets

Closed

3.

3/4/2023

REC/2023/003

Cosatrim DS

Sulfamethoxazole 800mg/Trimethoprim 160mg

210825, 210828

Cosmos Ltd, Kenya

Cracking along the tablet score line

Closed

2.

28/03/2023

REC/2023/002

Clindar B Capsules

Clindamycin 150mg

CBLOOICE-2925 CBL002CE-2640

Wallace Pharmaceuticals Ltd

The capsules crumbled and broke due to a defect in the primary packaging, which caused them to stick to the blister pack

Closed

1.

06/02/2023

REC/2023/001

Diprofos 7mg/ml 2ML AMP MEA

Betamethasone Dipropionate

W005050 W012878 W015902 W020203

W025759 W030457 W032602

Schering Plough Labo N.V.

Use of a potentially corroded component in the manufacture of the products

Closed