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Products Recalled in 2025

S/N

 

Date recall was initiated

Recall Reference Number

Product Name/ Category

(click to view the report)

INN Name (s)

Batch Number (s)

Name of Manufacturer

Reasons for recall

Status

9.

17/03/2025

REC/2025/009

Oxytocin Injection

Oxytocin BP 10IU/ML

MOEIE-003

Laborate Pharmaceuticals India Ltd

Failure to comply with the specifications on related substances test

Ongoing

8.

11/03/2025

REC/2025/008

Betamol Tablets

Paracetamol 500mg

01215PT

Sphinx Pharmaceuticals Ltd, Kenya

Out-of-Specification results on uniformity of weight

Ongoing

7.

11/03/2025

REC/2025/007

Medzol Tablets

Metronidazole 400mg

230940

Shanxi Xinyitong Pharmaceutical Co., Ltd, China

Out-of-Specification results on uniformity of weight

Ongoing

6.

11/03/2025

REC/2025/006

Metrosim Tablets

Metronidazole 200mg

003835

Africure Pharmaceuticals India Private Limited

Failure to comply with the specifications on friability test

Ongoing

5.

10/03/2025

REC/2025/005

Shaltoux Herbal Cough Syrup

Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol

24011

Gopaldas Visram & Company Limited, India

Market complaints of presence particulate matter in the product

Ongoing

4.

07/02/2025

REC/2025/004

APC Tablets

Paracetamol 250mg, Aspirin 150mg & Caffeine 30mg

1223038

Biodeal Laboratories Ltd, Kenya

Out-of-Specification results on uniformity of weight

Ongoing

3.

16/01/2025

REC/2025/003

TBcide

Sodium Hypochlorite Solution

24052101A2 and 24052201A2

Kenya Medical Research Institute (KEMRI)

Lack of the characteristic color and smell and formation of brown crystals on the product packaging.

Ongoing

2.

06/01/2025

REC/2025/002

Flurasted 500 Injection

5-Fluorouracil

HHP2401

Halsted Pharma Private Limited, India

Detection of particles in the product.

Ongoing

1.

03/01/2025

REC/2025/001

Bisotrol Tablets

Bisoprolol 5mg

JJI023002

Ipca Laboratories Limited, India

Out of specification (OOS) results observed in the Related Substances test of Bisotrol – 5 Tablet at 12M on 30C/75% stability conditions.

Ongoing