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Medicines: Suspensions from the ARTG

29 July 2020

Following a review by the TGA, medicines and other therapeutic goods can be suspended from the Australian Register of Therapeutic Goods. For listed and registered medicines, these suspensions are made by the Secretary under section 29D of the Therapeutic Goods Act 1989 (the Act).

If a suspension occurs because of a safety concern, the TGA considers whether other actions including a recall are necessary and takes those actions when required. Any safety-related actions will appear under 'Further information'.

The reasons for a suspension are stated in the database under 'Grounds for suspension'.

Medicine suspensions

Displaying 1 - 25 of 95

2020

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANOXYL HEARTBURN RELIEF ranitidine (as hydrochloride) 150mg blister pack

ARTG number: 100404

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jul 2020

Johnson & Johnson Pacific Pty Ltd

Product name: MYLANTA RANITIDINE 24 HOUR ACTION ranitidine 300mg (as hydrochloride) film-coated tablet blister pack

ARTG number: 116268

Type of regulatory action: Suspension from the ARTG under s.29D(1)(b)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: ARTG 116268 was cancelled from the Register by the sponsor on 5 December 2019, prior to the suspension coming into effect.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jul 2020

Sandoz Pty Ltd

Product name: RANITAL FORTE ranitidine 300mg (as hydrochloride) film-coated tablet blister pack

ARTG number: 117184

Type of regulatory action: Suspension from the ARTG under s.29D(1)(b)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: ARTG 117184 was cancelled from the Register by the sponsor on 26 June 2020.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Arrow Pharma Pty Ltd

Product name: CHEMISTS' OWN RANITIDINE FORTE ranitidine 300mg (as hydrochloride) tablet blister pack

ARTG number: 123658

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Arrow Pharma Pty Ltd

Product name: CHEMISTS' OWN RANITIDINE 150mg (as hydrochloride) tablet blister pack

ARTG number: 123670

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Aspen Pharmacare Australia Pty Ltd

Product name: ZANTAC ranitidine 150mg (as hydrochloride) dispersible tablet strip pack

ARTG number: 12535

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Aspen Pharmacare Australia Pty Ltd

Product name: ZANTAC ranitidine 50mg/2mL (as hydrochloride) injection ampoule

ARTG number: 12536

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Cipla Australia Pty Ltd

Product name: CIPLA REFLUX RELIEF EXTRA STRENGTH ranitidine (as hydrochloride) 300mg tablet strip pack

ARTG number: 128747

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: Ranoxyl Heartburn Relief Extra (ranitidine as hydrochloride) 300 mg tablet strip pack

ARTG number: 138512

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Apotex Pty Ltd

Product name: GenRx ACID & HEARTBURN RELIEF ranitidine 150mg (as hydrochloride) tablet blister pack

ARTG number: 143188

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medreich Australia Pty Ltd

Product name: MEDREICH RANITIDINE 300 MG TABLETS BP (as hydrochloride) blister pack

ARTG number: 146798

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medreich Australia Pty Ltd

Product name: MEDREICH RANITIDINE 150 MG TABLETS BP (as hydrochloride) blister pack

ARTG number: 146799

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANITIDINE-GA ranitidine (as hydrochloride) 150mg tablet blister pack

ARTG number: 148518

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANITIDINE-GA ranitidine 150mg (as hydrochloride) tablet bottle

ARTG number: 148519

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANITIDINE-GA ranitidine (as hydrochloride) 300mg tablet blister pack

ARTG number: 148520

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANITIDINE-GA ranitidine 300mg (as hydrochloride) tablet bottle

ARTG number: 148521

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: GN-RANITIDINE ranitidine 150mg (as hydrochloride) tablet bottle

ARTG number: 148524

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: GN-RANITIDINE ranitidine 300mg (as hydrochloride) tablet bottle

ARTG number: 148527

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANITIDINE WINTHROP ranitidine (as hydrochloride) 150mg tablet blister pack

ARTG number: 148528

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Medis Pharma Pty Ltd

Product name: RANITIDINE WINTHROP ranitidine (as hydrochloride) 300mg tablet blister pack

ARTG number: 148529

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Cipla Australia Pty Ltd

Product name: PRICELINE REFLUX RELIEF EXTRA STRENGTH ranitidine 300mg (as hydrochloride) capsule-shaped tablet blister strip pack

ARTG number: 151865

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jul 2020

Cipla Australia Pty Ltd

Product name: PHARMACY HEALTH REFLUX RELIEF EXTRA STRENGTH ranitidine 300mg (as hydrochloride) capsule-shaped tablet blister strip pack

ARTG number: 151866

Type of regulatory action: Suspension from the ARTG under s.29D(1)(b)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: ARTG 151866 was cancelled from the Register by the sponsor on 24 June 2020.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

AFT Pharmaceuticals Pty Ltd

Product name: ACIDSOOTHE ranitidine 150mg/10mL (as hydrochloride) oral liquid bottle

ARTG number: 163643

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Generic Health Pty Ltd

Product name: PHARMACY ACTION Heartburn & Acid Indigestion Relief ranitidine 150mg tablets (as hydrochloride) blister pack

ARTG number: 191837

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

Suspension start date: 28 Jan 2020

Suspension end date: 28 Jan 2021

Generic Health Pty Ltd

Product name: PHARMACY ACTION Heartburn & Acid Indigestion Relief Forte ranitidine (as hydrochloride) 300mg tablet blister pack

ARTG number: 191838

Type of regulatory action: Extension of suspension from the ARTG under s.29E(3)

Grounds for suspension

Under subsection 29D(1)(b); it is likely there are grounds for cancelling this medicine from the ARTG under section 30(2)(a) on the basis that the quality of the goods is unacceptable.

Further information: Suspension effective for 6 months. A decision was made to extend the suspension for a further 6 months in accordance with section 29E of the Act.

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