RECALLED PRODUCTS SINCE JANUARY, 2018

  1. FDA/USP ANTIMALARIALS AND ANALGESICS SURVEY

No.

Product Name

Manufacturer

Batch No.

Manufacturing

Date

Expiry Date

1.

Primadol 500mg Tablet

(Paracetamol 500mg)

Kinapharma Limited, Accra

16021

NIL

06-2020

2.

Primadol 500mg Tablet

(Paracetamol 500mg)

Kinapharma Limited, Accra

16022

NIL

06-2020

3.

Palidar Tablets (Sulphadoxine 500mg, Pyrimethamine 25mg)

Phyto-Riker (Ghana) Pharmaceuticals Ltd. Accra

051-U11684

11-2014

10-2018

4.

Malarid Tablets

Pharmanova Ltd, Accra

F008

06-2016

05-2020

5.

Novamol Tablets (Paracetamol 500mg)

Pharmanova Ltd, Accra

G046

08/2021

6.

Pocumol Tablets (Paracetamol 500mg)

Poku Pharma Limited, Kumasi

PM 59

11-2017

10-2021

 

  1. VALSARTAN CONTAINING PRODUCTS- due to contamination of API with Nitrosodiethylamine (NDEA) and Nitrosodimethylamine (NDMA) impurities

No.

Product Name

MA Holder

Manufacturer

API Source

Decision of FDA and Date of Letter

1.

Valsotens Tablets 80mg

Actavis Limited

Actavis Limited, UK

Zhejiang Huahai Pharmaceuticals, Linhai, China.

Recall, 11th Sept 2018

 

 

2.

Valsotens Tablets 160mg

Actavis Limited

Actavis Limited, UK

Zhejiang Huahai Pharmaceuticals, Linhai, China.

Recall, 11th Sept 2018

 

 

 

3.

Dopcor  80mg

Aspen Pharmacare Holdings

Torrent Pharmaceuticals Limited, Gujarat, India

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 11th Sept 2018

 

 

 

4.

Dopcor  80mg

Aspen Pharmacare Holdings

Torrent Pharmaceuticals Limited, Gujarat, India

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 11th Sept 2018

 

 

 

5.

**

Valsar-Denk 80mg

Denk Pharma GmbH & Co. KG, Germany

Denk Pharma GmbH & Co. KG, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 12th July 2018

6.

**

Valsar-Denk160mg

Denk Pharma GmbH & Co. KG, Germany

Denk Pharma GmbH & Co. KG, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 12th July 2018

7.

**

Valsar-Denk 320mg

Denk Pharma GmbH & Co. KG, Germany

Denk Pharma GmbH & Co. KG, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 12th July 2018

8.

**

CoValsar-Denk 80/12.5mg

Denk Pharma GmbH & Co. KG, Germany

Denk Pharma GmbH & Co. KG, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 12th July 2018

9.

**

CoValsar-Denk 160/12.5mg

Denk Pharma GmbH & Co. KG, Germany

Denk Pharma GmbH & Co. KG, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 12th July 2018

10.

**

CoValsar-Denk 320/12.5

Denk Pharma GmbH & Co. KG, Germany

Denk Pharma GmbH & Co. KG, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 12th July 2018

11.

Amva Denk 10/160, 5/160 and 5/80 Tablets

Denk Pharma

Sandoz Pharmaceuticals D.D, Ljubljana, Slovenia

Zhejiang Huahai Pharmaceuticals, Linhai, China

Recall, 11th December 2018

12.+++

Candesan 8mg and 16mg Tablets

Sandoz Pharmaceuticals D.D, Ljubljana, Slovenia

Sandoz Pharmaceuticals D.D, Ljubljana, Slovenia

Zhejiang Huahai Pharmaceuticals, Linhai, China

22 Nov 2018, no more import permit until API source is changed

13.+++

Hydrochlorthiazide 25mg Tablets

Hexal AG, Industriestrabe 25, Germany

Hexal AG, Industriestrabe 25, Germany

Zhejiang Huahai Pharmaceuticals, Linhai, China

22 Nov 2018, no more import permit until API source is changed

** Company carried out a voluntary recall

Products 1-10 were due to detection of impurities N- nitrosodiethylamine (NDEA) and nitrosodimethylamine (NDMA)

+++Products from 12 were due to non-compliance of manufacturing site by the USFDA

  1. ADULTERATED HERBAL MEDICINES/ FOOD SUPPLEMENTS

No.

Product Name

Manufacturer

Adulterant

 Date of Letter

1.

X Plus Men Power Bitter Syrup 

New Global Pharmaceuticals Limited,Plot  No 1 Light Industrial Area

Odorkor-Accra

Sildernafil

18th May 2018

 

2.

Anidaso Good man Capsules 

Dependable Pharmacy Limited

P. O. Box 9019

 KIA-Accra

Sildernafil

18th May 2018

 

3.

Laud P Capsules 

Steven Gyan Herbal Centre

P. O. Box ST 277

Kumasi

Sildernafil

18th May 2018

4.

Time Natural Capsules 

Kenoga Company Ltd

Esereso Adagya

Kumasi

Sildernafil

18th May 2018

5.

Vigoura Capsules 

Evergreen Healthcare Ghana Ltd

Community 9

Light Industrial Area

Tema

Sildernafil

18th May 2018

6.

Osompa Natural Capsules 

Dr. Afari James  Osompa Herbal Centre

P. O Box KN 4676

Kaneshie- Accra

Sildernafil

18th May 2018

  1. OTHER PRODUCT RECALLS (BATCH SPECIFIC)

No.

Product Name

Manufacturer/ Importer

Batch No.

Expiry Date

Date of Letter

1.*

Oxytocin Injection

Unicom Chemists Limited

P. O. Box OS 591

Osu-Accra

170521

05- 2020

5th  January  2018

2.*

Magnesium Sulphate injection 50%

Unicom Chemists Limited

P. O. Box OS 591

Osu-Accra

1T1016005

July 2019

5thFebruary 2018

3.**

Amoxcloson DS Oral Suspension

Swiss Parenterals PVT Limited

DP8116

09/2018

10th April 2018

4.**

Diclofenac Injection

(Diclofenac Sodium 75mg)

Darose Pharmacy Limited

Okaishie

Accra

14533-01

07-2019

16th July 2018

5.***

Lavet Feminine Hygiene Wash

Yamok Industries and Company Ghana Limited

P.O. Box 9551 Airport

Accra Ghana

24th August 2018

* Suspected lack of therapeutic effect.

**Substandard medication

*** Non-conforming packaging

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