This section provides information on the press release or notice to the public of a certain marketing authorization holder when a recall of their product is pursued. FDA Philippines posts the advisory of the company as a public service but does not endorse either the product or the company. For additional information on recalls, see http://a0933.com/category/drugs-advisories/.
|DATE||PRODUCT DESCRIPTION||BRAND NAME||MAH||REASON FOR RECALL||ANNOUNCEMENT|
|14 November 2022||Oxytocin 10 IU/mL Solution for Injection (IM/IV/SC)||Exerta||The Cathay Drug Co., Inc.||Quality defect||View PDF|
|01 August 2022||"Bromhexine Hydrochloride 8 mg Tablet and |
Hyoscine-N-Butylbromide 1 mg/mL (5 mg/5 mL) Syrup"
|"Pulmohex Hyospan"||Drugmakers Laboratories, Inc.||GMP Non-compliance||View PDF|
|01 July 2022||Gliclazide 30 mg Prolonged Release Tablet||"Azukon MR|
|"Torrent Pharma Philippines, Inc.|
TGP Pharma Inc."
|01 July 2022||"Ascorbic Acid 100 mg/5 mL Syrup [Myrevit C] and Ascorbic Acid 100 mg/mL Syrup (Oral Drops) [Myrevit C]"||Myrevit-C||New Myrex Laboratories, Inc.||Out-of-Specification||View PDF|
|29 March 2022||Gadoteric Acid 0.5 mmol/mL (equi. To 279.32 mg/mL) Solution for Injection (IV)||Dotarem||Fernando Medical Enterprises, Inc.||Quality defect||View PDF|
|March 23, 2022||Irbesartan-Containing Products||Aprovel|
|Sanofi-Aventis Philippines Inc.||Quality defect||View PDF|
|March 14, 2022||Gliclazide 30 mg Prolonged Release Tablet||AZUKON MR||Torrent Pharma Philippines, Inc.||Out-of-Specification||View PDF|
|02 December 2021||Losartan-containing products||-||Sandoz Philippines Corporation||Quality defect||View PDF|
|12 March 2021||Amoxicillin (as trihydrate) 125 mg/5 mL Powder for Suspension||Himox||UNILAB, Inc.||Misprinting of Labels||View PDF|
|01 March 2021||Cloxacillin (as sodium) 500mg capsule (Philclox)||Philclox||PhilRx Pharma Inc.||Out-of-Specification||View PDF|
|24 February 2021||Sertraline (as Hydrochloride) 50 mg Film-Coated Tablet||Serenata||Torrent Pharma Philippines, Inc.||Out-of-Specification||View PDF|
|08 January 2021||Ceftolozane + Tazobactam 1 g/500 mg Powder for Injection (IV)||Zerbaxa||Merck Sharp & Dohme (I.A.) LLC||Out-of-Specification||View PDF|