Sulfa Side Effects
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ABACAVIR ALBUTEROL AMIKACIN ATROPINE CAPREOMYC CLOPIDOGR CODEINE S CUPRIC SU EPHEDRINE FERRIC SU FERROUS S GENTAMICI HYOSCYAMI MAFENIDE MAGNESIUM MANGANESE MORPHINE NEOMYCIN NEOMYCIN, PAROMOMYC PHENELZIN POLYMYXIN PROTAMINE QUINIDINE QUININE S SILVER SU SODIUM SU SODIUM TH TERBUTALI TOBRAMYCI TRIMETHOP VINBLASTI VINCRISTI ZINC SULF
Active Ingredient: ABACAVIR ALBUTEROL AMIKACIN ATROPINE BACITRACI BUSULFAN CAPREOMYC CLOPIDOGR CODEINE S CUPRIC SU DEXAMETHA EPHEDRINE FERRIC SU FERROUS S GALSULFAS GENTAMICI HYOSCYAMI IDURSULFA ISOSULFAN MAFENIDE MAGNESIUM MANGANESE MORPHINE NEOMYCIN PAROMOMYC PHENELZIN POLYMYXIN PREDNISOL PROTAMINE QUINIDINE QUININE S SILVER SU SODIUM TH SULFACETA SULFADIAZ SULFAMETH SULFANILA SULFASALA TERBUTALI TOBRAMYCI VINBLASTI VINCRISTI ZINC SULF
Side Effects reported to FDA: 2149. View Sulfa Adverse Reports
Reported deaths: 58
Reported hospitalizations: 506
Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets
AUDIENCE: Pharmacy, Consumer
ISSUE: Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine HCl 25 mg tablets. The lot of the Rugby Ferrous Sulfate is 12G468. Expiration date for the lot is 07/14. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate -- see Product Photo page. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.
BACKGROUND: Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with kidney or liver dysfunction, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.
Consumers who take three tablets daily of the defective product for treatment of iron deficiency would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose.
RECOMMENDATION: Consumers who have the affected lot should not take the product. They may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300, Monday through Friday between 8:30 am and 4:30 pm ET.
Sulfa Adverse Reactions
Pyrexia ( 183 Reports)|Rash ( 165 Reports)|Nausea ( 133 Reports)|Renal Failure Acute ( 132 Reports)|Headache ( 111 Reports)|Hyperkalaemia ( 83 Reports)|Pruritus ( 82 Reports)|Asthenia ( 79 Reports)|Vomiting ( 78 Reports)|Stevens-johnson Syndrome ( 76 Reports)|Dyspnoea ( 75 Reports)|Diarrhoea ( 73 Reports)|Fatigue ( 69 Reports)|Pain ( 69 Reports)|Urticaria ( 62 Reports)|Chills ( 61 Reports)|Arthralgia ( 59 Reports)|Malaise ( 56 Reports)|Neutropenia ( 55 Reports)|Hypersensitivity ( 49 Reports)|Anaemia ( 47 Reports)|Erythema ( 46 Reports)|Abdominal Pain ( 45 Reports)|Dizziness ( 45 Reports)|Lymphadenopathy ( 45 Reports)|Hypotension ( 43 Reports)|Toxic Epidermal Necrolysis ( 43 Reports)|Cough ( 40 Reports)|Blood Creatinine Increased ( 39 Reports)|Decreased Appetite ( 37 Reports)|