🍔 Food 💊 Drugs 🏥 Medical Devices
Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90 Class II

Reason: Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Jubilant Cadista Pharmaceuticals Inc. 20140711 Terminated
Distributed: Nationwide and Puerto Rico
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triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78 Class II

Reason: Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

Teva Pharmaceuticals USA 20140401 Terminated
Distributed: Nationwide
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Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8, Class II

Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Fagron, Inc 20140724 Terminated
Distributed: Nationwide and Australia
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Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8. Class II

Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Fagron, Inc 20140724 Terminated
Distributed: Nationwide and Australia
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Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6. Class II

Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Fagron, Inc 20140724 Terminated
Distributed: Nationwide and Australia
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Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively. Class II

Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Dermamedics, L.L.C. 20140110 Terminated
Distributed: Nationwide
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