FDA

Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of ...

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Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. ...

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Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products

Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within ...

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Dougherty's Pharmacy - 500635 - 05/14/2020

Compounding Pharmacy/Adulteration/Misbranding

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Regulatory Education for Industry: Advancing Innovative Science in Generic Drug Development Workshop - 09/29/2020 - 09/30/2020

Workshop

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Les Produits Chimiques B.G.R., Inc. - 542247 - 05/21/2020

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

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Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) - 07/23/2020 - 07/23/2020

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription ...

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PDUFA VII: Fiscal Years 2023 – 2027

Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and ...

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Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval

Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin ...

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Synergy Rx Pharmacy Issues a Voluntary Nationwide Recall of the Products Listed Below due to a Lack of Quality Assurance

San Diego, CA, Synergy Rx Pharmacy is voluntarily recalling the following non-sterile products; Sublingual Tablets, HCG and HCG with resveratrol Human ...

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Synergy Rx Pharmacy Issues Voluntary Nationwide Recall of All Lots of HCG (Human Chorionic Gonadotropin)Freeze Dried Vials Due to a Lack of Sterility Assurance

Synergy Rx Pharmacy is voluntarily recalling all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a ...

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Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency

Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced ...

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Advanced Pharma, Inc. d/b/a Avella of Houston Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Repacked and/or Compounded at its Houston Location as a Result of Hospira, Inc’s June 15, 2017 Recall of Such Pro

Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June ...

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Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference

Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were ...

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Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, ...

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International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Pravastatin Sodium Tablets USP, 40mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-925-16; Lot # 115698A

International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer ...

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Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration.

Lake Forest, IL PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL ...

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PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of ...

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Coronavirus (COVID-19) Update: Daily Roundup May 20, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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Teva Pharmaceuticals, USA Extends Voluntary Nationwide Recall to Consumer/User Level for One Lot of Paliperidone Extended-Release Tablets, 3mg, 90 Count Bottles Distributed Under the Actavis Pharma Inc. Label Due to Dissolution Test Failure

Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 ...

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Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient

Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using ...

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ICU Medical Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer ...

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Hospira Issues A Voluntary Nationwide Recall For One Lot Of Vancomycin Hydrochloride for Injection, USP Due To The Presence of Particulate Matter Within a Single Vial

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date ...

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Emedkit.com - 606138 - 04/22/2020

Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19)

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SpiceTac - 607144 - 05/19/2020

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer ...

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Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary ...

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Coronavirus (COVID-19) Update: Daily Roundup May 19, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance

Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during ...

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Astrazeneca Initiates Voluntary Nationwide Recall of One Lot of Brilinta 90 mg Professional Sample Bottles Due to Report of Another Medicine in One Bottle From That Lot

AstraZeneca today announced that the Company is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample ...

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First Generic Drug Approvals

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice ...

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Hieber's Pharmacy - 542220 - 05/01/2020

Compounding Pharmacy/Adulterated Drug Products

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COVID-19 Real World Data (RWD) Data Elements Harmonization Project

Harmonize a list of COVID-19 data elements with several Common Data Models (CDMs) and open standards

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Division of Applied Regulatory Science - A Sampling of DARS Projects

Biomedical and Chemical Informatics; Adverse Event Profiling; Modeling to Inform Scheduling of Novel Substances of Abuse Potential; Chemical Structure-Activity ...

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C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength

Bellmawr, New Jersey, C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer ...

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, Due to Presence White Particulate Matter that has been Identified as Mold

AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August ...

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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. ...

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Fresenius Kabi Issues Voluntary Nationwide Recall of Midazolam Injection, USP, 2 mg/2 mL Due to Reports of Blister Packages Containing Syringes of Ondansetron Injection, USP, 4 mg/2 mL

Fresenius Kabi USA is voluntarily recalling Lot 6400048 of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the ...

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Marmex Corp Issues Voluntary Nationwide Recall of Blue Pearl All Natural Male Enhancement Supplement, Due to Undeclared Sildenafil

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has ...

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Coronavirus (COVID-19) Update: Daily Roundup May 18, 2020

Coronavirus (COVID-19) Update: Daily Roundup

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FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

FDA approved atezolizumab (TECENTRIQ®, Genentech Inc.) for first-line treatment of patients with metastatic non-small cell lung cancer with high PD-L1 ...

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Ridge Properties DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of all Lots of Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid Products Due to Manufacturing Concerns at the Facility

Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT ...

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Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues

Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were ...

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Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer Due to Microbial Contamination

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: ...

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SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination

SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital ...

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Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures

Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed ...

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Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were ...

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