PPB - Services

Complaints, Feedback and Enquiry

Products Recalled in 2022

S/N

Date recall was initiated

Product Name/ Product Category

INN Name (s)

Batch Number(s)

Name of Manufacturer

Reasons for recall

11

14/12/2022

Famcal tablets

Calcium citrate maleate with Cholecalciferol

FDF1AD3B

Indoco Remedies Limited, Industrial area, M.DI.D.C, Thane Belapur Road, Mumbai

Out of specification of results of assay testing on stability studies program at 9M time point

10

13/12/2022

Umbicare gel

Chlorhexidine Gluconate Gel 7.1% w/w

UAM1IC1B

Indoco Remedies Limited, Industrial area, M.DI.D.C, Thane Belapur Road, Mumbai

Out Of Specification results on testing of related substances

9

07/12/2022

Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir (300/300/50mg) tablets

Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir (300/300/50mg) tablets

Several

Universal Corporation Limited

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

8

12/09/2022

Biodine mouth gargle

Povidone Iodine mouth gargle

0122081, 0122082, 0322054, 0322056 and 0322057

Biodeal Laboratories Ltd

Market complaint on discoloration of the products and review of retained and stability samples

7

01/07/2022

Rocephin I g Injection

Ceftriaxone 1 g injection

B0752B04

Siegfried Hameln in Germany manufactured for ROCHE

Detection of pinholes in 10 mL Water for Injection (WFI) ampoules used in Rocephin 1.000 g finished products

6

24/06/2022

EEATM Auto SutureTM Circular Stapler with DST SeriesTM Technology 25mm 

Intraluminal circular stapler 

All

Covidien llc 15 Hampshire Street Mansfield, USA

A complaint was received for EEATM AutosutureTM Circular Stapler with DST SeriesTM Technology (EEAXL2535) 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. Further tissue dissection and manipulation was required to recreate tissue and the gastric pouch for anastomosis. The case was completed by using another stapler. The surgical time was extended by at least 2 hours and hospitalization for 1 day. One EEAXL2535 instrument was received at Medtronic manufacturing for evaluation of the reported conditions of “Staples Did Not Deploy” and “Disengaged Staple Guide”.                                          The staple guide was not attached to the instrument, and it was not received for evaluation. The weld witness marks were not observed at the inner area of the shell, which is an indication of improper staple guide assembly. 

5

24/06/2022

Dawaflox DPS suspension 100ML

Flucloxacillin

2006121, 2012085

Dawa Lifesciences Ltd

Failure of assay during stability studies

4

06/04/2022

Biodopa 250mg tablets

Methyldopa

0321077 and 0421112

Biodeal Laboratories Ltd

Discoloration of the tablets

3

07/03/2022

Vasofix certo G24X19MM yellow

Peripheral vascular infusion catheter

20A19G8334, 20A21G8381

B.Braun Melsungen AG (BBMAG)

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.

2

21/02/2022

ALKAR-UR effervescent granule satchets

Sodium bicarbonate 1.76g, Tartaric acid 0.890g, Citric acid anhydrous 0.720g and trisodium citrate anhydrous

3620100

National Pharmaceutical Industries Co. (SAOC), Sultanate of Oman

Sachets bloated and powder agglomerated

1

14/01/2022

Pregsmile tablets 3 *10s

Doxylamine/Pyridoxine / Folic acid

EKE-235

Corona Remedies Pvt.Ltd, India

Mix up (found to contain blister of Rosuvastatin)