PPB - Services

Complaints, Feedback and Enquiry

Products Recalled in 2017

S/N

Date recall was initiated

Product Name/ Product Category

INN Name (s)

Batch Number(s)

Name of Manufacturer

Reasons for recall

1

29/03/2017

Clopidogrel with Aspirin

Clopidogrel and Aspirin

E31614002

Unicure Remedies

The product failed dissolution test, assay test and weight variation

2

05/04/2017

Dulcolax 5mg

Bisacodyl

160697

Boehringer

Detected Out of specification for dissolution test

3

12/05/2017

Asmol 500mg

Paracetamol

2769 and 2019

Astra Lifecare Ltd

Moulding of tablets

4

12/11/2017

Glucose 5D

Dextrose

1015461

Shree Krishna Keshav Lab Ltd

Particulate matter

5

13/11/2017

Claxy 228.5mg

Amoxicillin and Clavulanic acid

EBD170033

Theon Pharmaceuticals ltd

Color change

6

13/11/2017

Rhoclone 300mcg

Anti Rho-D Immunoglobulin

Missing

Bharat Serums and Vaccines Ltd

Product lacks proper labelling, batch number, DOM, DOE

7

13/11/2017

Festate tablet

Ferrous Sulphate

WG14295

Westcoast Pharmaceutical works

Color change and appearance of dark spots on tablets

8

16/11/2017

Upacof Syrup

Diphenhydramine and Promethazine

510235 and 610120

Universal Corporation Ltd

The product has an OOS result for Promethazine content

9

20/11/2017

Erocin Powder for reconstitution

Erythromycin

67473, 64685

Laboratory and Allied Ltd

Unpleasant taste and odor, lumping

10

23/11/2017

Dinac gel

Diclofenac

All batches

Universal Corporation Ltd

The product failed to comply with assay, description, and related substances

11

07/12/2017

Methomine S

Sulfadoxine and Pyrimethamine

421214

Universal Corporation Ltd

Color change