Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
Dermamedics, L.L.C.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Sandoz Incorporated
Class I - Dangerous
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
Mckesson Packaging Services
Class I - Dangerous
Failed Dissolution Specification; at the 12 month time interval.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
Dermamedics, L.L.C.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
Dermamedics, L.L.C.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class I - Dangerous
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
Shamrock Medical Solutions Group
Class I - Dangerous
Labeling: Label Mix up; product labeled did not indicated Extended Release
Class I - Dangerous
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
X-Gen Pharmaceuticals
Class I - Dangerous
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
Shamrock Medical Solutions Group
Class I - Dangerous
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Class I - Dangerous
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Class I - Dangerous
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.