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/.
DATE | PRODUCT DESCRIPTION | BRAND NAME | MAH | REASON FOR RECALL | ANNOUNCEMENT |
---|---|---|---|---|---|
02 March 2023 | Betamethasone diproprionate/Betamethasone Sodium Phosphate 5 mg/2 mg Suspension | Diprospan | Organon (Philippines), Incorporated | Quality Defect | View PDF |
16 February 2023 | Cloxacillin (as sodium) 125 mg/5 mL Powder for Oral Suspension | Cloxasaph-125 | Nelpa Lifesciences, Inc. | Out-of-Specification | View PDF |
16 February 2023 | Erdosteine 300 mg Capsule | Ectrin | OEP Philippines, Inc. | Out-of-Specification | View PDF |
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 TGP" | "Torrent Pharma Philippines, Inc. TGP Pharma Inc." | Out-of-Specification | View 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-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 Co-Aprovel Aprovasc | 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 |
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