FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
by Sandoz Incorporated
- Reason
- Presence of Foreign Substance; tablets may contain stainless steel metal particulates
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Jubilant Cadista Pharmaceuticals Inc.
- Reason
- Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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,
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
by Dermamedics, L.L.C.
- Reason
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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