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Company/MAH Recall Announcement

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 https://www.fda.gov.ph/category/drugs-advisories/.

DATEPRODUCT DESCRIPTIONBRAND NAMEMAHREASON FOR RECALLANNOUNCEMENT
14 November 2022Oxytocin 10 IU/mL Solution for Injection (IM/IV/SC) ExertaThe Cathay Drug Co., Inc.Quality defectView 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-complianceView PDF
01 July 2022Gliclazide 30 mg Prolonged Release Tablet"Azukon MR
TGP"
"Torrent Pharma Philippines, Inc.
TGP Pharma Inc."
Out-of-SpecificationView PDF
01 July 2022"Ascorbic Acid 100 mg/5 mL Syrup [Myrevit C] and Ascorbic Acid 100 mg/mL Syrup (Oral Drops) [Myrevit C]"Myrevit-CNew Myrex Laboratories, Inc.Out-of-SpecificationView PDF
29 March 2022Gadoteric Acid 0.5 mmol/mL (equi. To 279.32 mg/mL) Solution for Injection (IV)DotaremFernando Medical Enterprises, Inc.Quality defectView PDF
March 23, 2022Irbesartan-Containing ProductsAprovel
Co-Aprovel
Aprovasc
Sanofi-Aventis Philippines Inc.Quality defectView PDF
March 14, 2022Gliclazide 30 mg Prolonged Release Tablet AZUKON MRTorrent Pharma Philippines, Inc.Out-of-SpecificationView PDF
02 December 2021Losartan-containing products-Sandoz Philippines CorporationQuality defectView PDF
12 March 2021Amoxicillin (as trihydrate) 125 mg/5 mL Powder for SuspensionHimoxUNILAB, Inc.Misprinting of LabelsView PDF
01 March 2021Cloxacillin (as sodium) 500mg capsule (Philclox)PhilcloxPhilRx Pharma Inc.Out-of-SpecificationView PDF
24 February 2021Sertraline (as Hydrochloride) 50 mg Film-Coated TabletSerenata
Torrent Pharma Philippines, Inc.Out-of-SpecificationView PDF
08 January 2021Ceftolozane + Tazobactam 1 g/500 mg Powder for Injection (IV)ZerbaxaMerck Sharp & Dohme (I.A.) LLCOut-of-SpecificationView PDF
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