PPB - Services

Complaints, Feedback and Enquiry

Products Recalled in 2019

S/N

Date recall was initiated

Product Name/ Product Category

INN Name (s)

Batch Number(s)

Name of Manufacturer

Reasons for recall

1

02/01/2019

Fiesta stamina

Condoms

DL1608

DKT

Failed freedom from holes test

2

02/01/2019

Fiesta Big Black

Condoms

PL1625

DKT

Failed thickness test

3

18/01/2019

Jotonol 500mg

Paracetamol

T00418

Benmed Pharmaceuticals

The batch failed dissolution test

4

18/01/2019

Zegra 50mg

Sildenafil

00-218

Benmed Pharmaceuticals

The batch failed assay test, dissolution test and uniformity of weight

5

15/02/2019

Cipcina tablet

Ciprofloxacin

170520

Shanxi Xinyitong Pharmaceutical Co. Ltd

Failed assay test

6

18/02/2019

ABZ tablet

Albendazole

ABX1B83

Indoco remedies

the batches failed Dissolution test

7

25/02/2019

Trogyl tablets

Metronidazole

0418033, 0418034

Biodeal Laboratories Ltd

Black spots on the tablets

8

25/02/2019

Silvadine cream 1%

Silver Sulfadiazine

0618003, 1118099

Biodeal Laboratories Ltd

Voluntary recall following a PPB notification of market complaint on PQMP

9

24/04/2019

Levonogets 0.75mg

Levonogestrel

P17G003

Olive Healthcare, India

The batch failed dissolution test, weight variation and Assay

10

09/05/2019

Sure lubricated condoms dotted

Condoms

P48045, L48037, P48001,P48001, P48027

HLL Lifecare,

Out of specification for freedom from holes and quantity of lubricant

11

09/05/2019

Sure lubricated condoms dotted

Condoms

17DN754, 17DN052

Innolatex Thailand Ltd

Out of specification for freedom from holes and quantity of lubricant

12

18/06/2019

Toramin syrup

Chlorpheniramine

180626

Comet Healthcare

Color change

13

03/07/2019

Wombit tablet

Albendazole

0218071, 0218072, 0317120, 0717073

Biodeal Laboratories Ltd

Failed dissolution testing

14

28/08/2019

Atazor-R

Atazanavir/Ritonavir 300/100MG

EM83045, EM803076

Emcure Pharmaceuticals Ltd

due to an Out of trend result for Hydroxy ritonavir impurity at 12 month stability time point

15

19/09/2019

Atazor-R

Atazanavir/Ritonavir 300/100MG

All batches

Emcure Pharmaceuticals Ltd

Product was out of trend at 12 months when stored at 30/75% RH

16

19/09/2019

Atazor-R

Atazanavir/Ritonavir 300/100MG

EM83045

Emcure Pharmaceuticals Ltd

Product was Out of trend results at 12 months when stored at 30/75% RH. Recall was specific to 500,000 pack of 30s supplied to NASCOP through KEMSA

17

01/10/2019

Kemoxyl DT 250mg

Amoxicillin

69660

Laboratory and Allied Ltd

The batch failed dissolution test

18

10/11/2019

Silvamax cream

Chlorhexidine,silver sulfadiazine

5804914

Universal Corporation Ltd

The batch reported stability falure for CHX content

19

20/11/2019

Alben oral suspension

Albendazole

54517008

GSK

The batch failed Assay test