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Products Recalled in 2023

S/N

 

Date recall was initiated

Product Name/ Product Category

INN Name (s)

Batch Number(s)

Name of Manufacturer

Reasons for recall

17.

15/11/2023

Lasideal 40mg Tablets

Furosemide

0621126

Biodeal Laboratories Ltd

Black Spots on the tablets

16.

15/11/2023

Enril 5 Tablets

Enalapril Maleate

KN532

Prism Life Sciences LTD, India

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

15.

17/10/2023

Beeclav 457mg Oral Suspension

Amoxicillin & Clavulanate Potassium

SEBPD-0088

Saitech Medicare PVT LTD, India

Color change to brown after reconstitution

14.

18/09/2023

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 Labroaratories LTD, India

The product
shows signs of
degradation

13.

18/09/2023

Oralex C Mouthwash

Chlorhexedine Gluconate & Benzydamine Hydrochloride Mouth Wash

L220077

Curis Lifesciences PVT LTD, India

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

12.

18/09/2023

Trimoxol Oral Solution

Cotrimoxazole 240mg/5ml

2210033; 2205033; 2210005; 2201145; 2207184

Dawa LTD, Kenya

Bitter taste of the suspension, rendering its administration difficult for pediatric patients

11.

18/09/2023

Tamedol Suspension

Paracetamol 120mg/5ml

All

Biopharma LTD, Kenya

Failure to meet prescribed market authorization requirements

10.

21/08/2023

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

9

17/08/2023

DTO Tablets

Ofloxacin USP 200mg and Ornidazole 500mg

DDBR2201

Coral Laboratories Ltd, India

Visible dark spots on the orange-colored tablets

8

15/06/2023

Mesporin

Ceftriaxone 500mg, 1000mg, 2000mg

Z0142Z0153, Z0030Z0129, Z0086Z0115, Z0149, Z0057, Z0107

Labestfal Almiro Laboratories S.A., Portugal

Visible particles in reconstituted powder of the product

7

01/06/2023

Denk-Air Junior

Montelukast 4mg

27084

Denk Pharma GmbH & Co. KG, Germany

Out of specification result in ongoing stability study

6

8/5/2023

Normnil

Albendazole 400mg

2103104; 2012082; 2007067; 2007098; 2006202; 2006200;

Dawa life sciences

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

5

3/5/2023

Fluconazole

Fluconazole 200mg

5810959; 5810961;

5810962;

5810960;

5811120;

5811121; 5811122; 5811123;

5811124;

5811125;

5811182; 5811183;

5811184; 5811185; 5810958; 5810959;

5810316; 5810320; 5810317;

Universal Corporation Limited

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

4

25/4/2023

Dopamac

Methyldopa 250mg

HMX20007A; HMX20008A; HMX20009A

Macleods pharmaceuticals Ltd

Color change, molding, tablet cracking

3

3/4/2023

Cosatrim DS

Sulfamethoxazole 800mg/Tri methoprim 160mg

210825; 210828;

Cosmos Ltd

The tablets are fragmented and broken along the designated break lines, resulting in two or more separate pieces.

2

28/03/2023

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

1

06/02/2023

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