🍔 Food 💊 Drugs 🏥 Medical Devices
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. 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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Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005 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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Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019 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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Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068. 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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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. 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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Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008. 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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Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. 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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Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 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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OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41. Class III

Reason: Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

Boehringer Ingelheim Roxane Inc 20140728 Terminated
Distributed: U.S. Nationwide
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Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30 Class III

Reason: Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.

Pfizer Inc. 20140619 Terminated
Distributed: Nationwide (Continental USA and Puerto Rico). A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market. One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope. Only the product distributed within US/PR market (bottles) is in the scope of this recall.
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Data provided by openFDA