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Products Recalled in 2022

 

S/N

Recall Date

Recall Ref No.

Product Name

IIN

Batch(es)

Manufaturer

Reason for recall

Status

11.

14/12/2022

REC/2022/011

Famcal tablets

Calcium citrate maleate with Cholecalciferol

FDF1AD3B

Indoco Remedies Limited, India

Out of specification results on assay test identified during stability studies

Closed

10.

13/12/2022

REC/2022/010

Umbicare gel

Chlorhexidine Gluconate Gel 7.1% w/w

UAM1IC1B

Indoco Remedies Limited, India

Out Of Specification results on related substances tests

Closed

9.

07/12/2022

REC/2022/009

Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir 

Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir 300/300/50mg

Several

Universal Corporation Limited, Kenya

Discoloration of induction seal, broken tablets and black spots on the tablets

Closed

8.

12/09/2022

REC/2022/008

Biodine Mouth Gargle

Povidone Iodine

0122081, 0122082, 0322054, 0322055, 0322056, 0322057

Biodeal Laboratories Ltd, Kenya

Change of color to colorless

Closed

7.

01/07/2022

REC/2022/007

Rocephin Ig Injection

Ceftriaxone 1g

B0752B04

F. Hoffmann-La Roche Ltd, Kaiseraugst

Detection of pinholes in 10 mL Water for Injection (WFI) ampoules

Closed

6.

24/06/2022

REC/2022/006

EEATM Auto SutureTM Circular Stapler with DST SeriesTM Technology 25mm

Intraluminal circular stapler 

All

Covidien llc 15 Hampshire Street Mansfield, USA

A complaint was reported as “Staples Did Not Deploy”. According to the reporter, during laparoscopic procedure the circular stapler was able to fire, but the staples did not deploy when attempting to staple a small bowel segment to the gastric pouch.

Closed

5.

24/06/2022

REC/2022/005

Dawaflox DPS suspension 100ml

Flucloxacillin

2006121, 2012085

Dawa Lifesciences Ltd

Failure of assay identified during stability studies

Closed

4.

06/04/2022

REC/2022/004

Biodopa tablets

Methyldopa 250mg

0321077, 0421112, 0421142

Biodeal Laboratories Ltd

Discoloration of the tablets

Closed

3.

07/03/2022

REC/2022/003

Vasofix certo G24X19MM yellow

Peripheral vascular infusion catheter

20A19G8334, 20A21G8381

B.Braun Melsungen AG

A defect on the injection port that may result in potentially critical clinical consequences for the patient e.g blood loss, underdosage or delay of therapy. Third party are at risk being inContact with patients fluids.

Closed

2.

21/02/2022

REC/2022/002

Alkar-UR effervescent granule satchets

Sodium Bicarbonate 1.76g, Tartaric Acid 0.890 g, Citric acid anhydrous 0.720g, Trisodium citrate anhydrous 0.630 gm

3620100

National Pharmaceutical Industries Co (SAOG) Muscat, Sultanate of Oman

Sachets bloated and powder agglomerated

Closed

1.

14/01/2022

REC/2022/001

Pregsmile tablets

Doxylamine/ Pyridoxine/

Folic acid

EKE-235

Corona Remedies Pvt.Ltd, India

Mix up (found to contain blisters of Rosuvastatin)

Closed