PPB - Services

Complaints, Feedback and Enquiry

Products Recalled in 2018

S/N

Date recall was initiated

Product Name/ Product Category

INN Name (s)

Batch Number(s)

Name of Manufacturer

Reasons for recall

1

13/03/18

Altacef Suspension

Cefuroxime

320416047, 320416050, 320616051, 320416060, 7320001, 7320002

Glenmark Pharmaceuticals

Voluntary recall

2

04/04/18

Metrowin 200

Metronidazole

150810

Shandong Xier Kangtai

Color change

3

07/04/18

Ventil 4mg

Salbutamol

815109

Biodeal Laboratories Ltd

The product is reported to have inconsistent colouration and dark brown spots

4

12/04/18

Moods Ultrathin Condoms

Condoms

L45UT009

HLL Lifecare Ltd

The batch failed Freedom from holes test

5

25/06/18

Zeosorb

Food supplement

All batches

Bayer AG Leverkusen

Voluntary withdrawall

6

06/08/18

Safil and Novosyne sutures

Sutures

717394, 717432, 717436, 718035

B. Braun Surgical S.A

Voluntary recall

7

20/09/2018

Fiesta Stamina

Condoms

DL1608

Cupid Ltd

batch failed freedom from holes test

8

20/09/2018

Fiesta Big Black

Condoms

PL1625

Cupid Ltd

batch failed thickness test

9

17/10/2018

Fluphenazine Decanoate injection

Fluphenazine

70327

Rotexmedica Germany

Voluntary recall due to OOS for the assay test

10

15/11/2018

Zenagent

Gentamicin

IZGIE001,IZGIE002, IZGIE003, IZGIE004

Laborate Pharmaceuticals

Adverse Event following adminstartion

11

20/11/2018

Elymox 125mg/5ml

Amoxicillin

8-E62

Elys Chemical Industries Ltd

the batch failed Assay test

12

20/11/2018

Labmox 125 Oral suspension

Amoxicillin

ILBDE-003

Laborate Pharmaceuticals

The batch failed Assay test

13

20/11/2018

Strox 500mg

Ciprofloxacin

5802163

Universal Corporation Ltd

The batch failed dissolution test

14

20/11/2018

Rough rider studded

Condoms

1509031616

Ansell Healthcare

The batch failed width test

15

20/11/2018

Acepril 5mg

Enalapril

70439, 72061

Laboratory and Allied Ltd

the batches failed Dissolution test

16

20/11/2018

Parol Oral Suspension

Paracetamol

180277

Atabay Ilac

the batch failed Assay test

17

26/11/2018

Wombit tablet

Albendazole

0218071, 0218072, 0317120, 0717071

Biodeal Laboratories Ltd

Failed dissolution testing

18

28/11/2018

Almex tablets

Albendazole

8AO2938

Square Pharmaceuticals

The batch failed dissolution test