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Medicines: Suspensions from the ARTG

18 November 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 114

2020

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Arrow Pharma Pty Ltd

Product name: AUSRAN ranitidine 150mg (as hydrochloride) tablet bottle

ARTG number: 104814

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Arrow Pharma Pty Ltd

Product name: AUSRAN ranitidine 300mg (as hydrochloride) tablet bottle

ARTG number: 104815

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Apotex Pty Ltd

Product name: TERRY WHITE CHEMISTS RANITIDINE ranitidine 150mg (as hydrochloride) tablet blister pack

ARTG number: 121975

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Apotex Pty Ltd

Product name: CHEMMART RANITIDINE ranitidie 150mg (as hydrochloride) tablet blister pack

ARTG number: 121976

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Apotex Pty Ltd

Product name: TERRY WHITE CHEMISTS RANITIDINE ranitidine 300mg (as hydrochloride) tablet blister pack

ARTG number: 121978

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Apotex Pty Ltd

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

ARTG number: 121979

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Apotex Pty Ltd

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

ARTG number: 122013

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Apotex Pty Ltd

Product name: APO-RANITIDNE ranitidine 300mg (as hydrochloride) tablet blister pack

ARTG number: 122014

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Alphapharm Pty Ltd

Product name: RANI 2 ranitidine 300mg (as hydrochloride) tablet blister pack

ARTG number: 285693

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Alphapharm Pty Ltd

Product name: RANI 2 ranitidine 300mg (as hydrochloride) tablet bottle

ARTG number: 285694

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Alphapharm Pty Ltd

Product name: RANI 2 ranitidine 150mg (as hydrochloride) tablet bottle

ARTG number: 285695

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Alphapharm Pty Ltd

Product name: RANI 2 ranitidine 150mg (as hydrochloride) tablet blister pack

ARTG number: 285696

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Avallon Pharmaceuticals Pty Ltd

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

ARTG number: 308525

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Avallon Pharmaceuticals Pty Ltd

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

ARTG number: 308526

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Alphapharm Pty Ltd

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

ARTG number: 59090

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Alphapharm Pty Ltd

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

ARTG number: 59091

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Sandoz Pty Ltd

Product name: RANITIDINE SANDOZ ranitidine 50mg/5mL (as hydrochloride) concentrated injection ampoules

ARTG number: 75771

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Arrow Pharma Pty Ltd

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

ARTG number: 97354

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: Suspension effective for 6 months.

Suspension start date: 17 Dec 2020

Suspension end date: 17 Jun 2021

Arrow Pharma Pty Ltd

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

ARTG number: 97355

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: Suspension effective for 6 months.

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.

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