Mirgen Pharmaceutical: The label around the neck of the dietary supplement bottle is in Spanish language only and it also makes claims. The manufacturer's label was covered by a Spanish language label.; The booklet around the neck of the dietary supplement bottle makes unapproved drug claims in Spanish. The orginal manufacturer's label was covered by a distributor's sticker label.; The booklet around the neck of the dietary supplement bottle makes unapproved drug claims in Spanish. The origin

Agency: Food and Drug Administration (FDA)

Event ID: 61148

Status: Resolved

Manufacturer: Mirgen Pharmaceutical

Manufactured In: United States

Units Affected: 19 products (202 bottles/24 capsules/285 mg; 120 bottles/100 soft gel/1000 mg; 72 bottles/60capsules; 120 bottles/60 capsules/50 mg; 144 bottles/60 capsules/1000 mg; 72 bottles/30 Coated Tablets/10 mg; 96 bottles/30 capsules/50 mg; 75 bottles/60 capsules/100mg/200 mg.; 157 bottles/60 capsules/400 mg; 92 Bottles/60 capsules/ 1.5 mg; 190 bottles/60 capsules/1000 mg; 96 bottles/200 capsules; 48 Bottles/90 capsules/25 mg; 96 bottles/60 Coated Tablet/300 mg Acai; 206 bottles/100 softgel, 1000 mg; 96 bottles/90 capsules/60 mg; 83 Bottles/60 Tablets, 5 mg Zinc; 96 Bottles/90 Capsules/250 mg; 162 Bottles/90 Coated Tablets/25 mg)