Summary Company Announcement Date: January 07, 2020 FDA Publish Date: January 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Appco Pharma LLC Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Appco Pharma LLC (Appco) is voluntarily recalling all quantities and…
Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength
Summary Company Announcement Date: December 30, 2019 FDA Publish Date: December 31, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to a label error on declared strength-bottles labeled as Mirtazapine 7.5 mg Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Aurobindo Pharma USA, Inc. Product Description: Product Description Mirtazapine Tablets…
Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product (Include the following information) CrossCath® Support Catheter Lot Numbers: 9945302, 9945303, 9953512, 9945301, 9950878, 9953506 Model Numbers: CXC3.0-1.9-14-90-P-NS-0, CXC3.4-2.2-18-90-P-NS-0, CXC3.4-2.2-18-135-P-NS-0, CXC3.4-2.2-18-150-P-NS-0 Manufacturing Dates: August 13, 2019 to…
Mavidon Issues Voluntary Worldwide Recall of all Manufactured Products Due to Burkholderia cepacia Contamination
Summary Company Announcement Date: December 23, 2019 FDA Publish Date: December 23, 2019 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Burkholderia cepacia Company Name: Mavidon Brand Name: Brand Name(s) LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep Product Description: Product Description LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep…
Motto International Corp. Issues Voluntary Recall of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, Due to Presence of Undeclared Tadalafil
Summary Company Announcement Date: December 17, 2019 FDA Publish Date: December 17, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Undeclared Tadalafil Company Name: Motto International Corp Brand Name: Brand Name(s) No Brand name Listed on Package Product Description: Product Description Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000,…
Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination
Summary Company Announcement Date: December 18, 2019 FDA Publish Date: December 18, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Bacillus subtilis Company Name: Lannett Company, Inc. Brand Name: Brand Name(s) Product Description: Product Description Levetiracetam Oral Solution Company Announcement Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots…
Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Medfusion® 4000 Syringe Pump with Firmware Version 1.7.0 Model numbers 4000-0107-01 and 4000-0106-01 Manufacturing Dates: June 25, 2019 Distribution Dates: September 27, 2019 to October 31, 2019…
LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Recalled Product(s): VNS Therapy SenTiva Generator System Model Number: 1000 Distribution Dates: Pre-screen Distribution Dates: April 19, 2019 – Sept 30, 2019 Post-screen Distribution Dates: July 31,…
Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication – Serious Breathing Problems
[Posted 12/19/2020] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as…
Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: December 17, 2019 FDA Publish Date: December 17, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Glenmark Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall…