Supply of the products Erythromycin by Link Medical Products

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

On December 17, 2013 the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:

(a)   the supply of the products:

• erythromycin (as ethylsuccinate) (EES) 200 mg/5 mL granules for oral liquid bottle [Aust R 173634].
• erythromycin (as ethylsuccinate) (EES) 400 mg/5 mL granules for oral liquid bottle [Aust R 54456].

  by Link Medical Products WARRIEWOOD, NSW (“the Company”);

That does not conform with paragraphs 3(2)(1) of Therapeutic Goods Order (TGO) 69, in that the carton label states the previous sponsors contact details.

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

• This consent applies to batch numbers;
  1. 6027413-15943 & 6031633-18580 (200 mg/5 mL)
  2. 6024719-7490, 6024720-10018 & 6024721-10110 (400 mg/5 mL);
• The bottle labels state the current address (Apollo Street, Warriewood NSW) and the cartons state the old address (Prosperity Parade, Warriewood NSW).
• Arrangements are in place to redirect all written correspondence to the current address.
• No other changes have been made to the products:

• erythromycin (as ethylsuccinate) (EES) 200 mg/5 mL granules for oral liquid bottle        [Aust R 173634].
• Erythromycin (as ethylsuccinate) (EES) 400 mg/5 mL granules for oral liquid bottle        [Aust R 54456].