April 1, 2020DrugsFDA
Matthew 7:25 Inc dba Thrive Pharmacy recalls Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 28
Hazard: Subpotent Drug
April 1, 2020DrugsFDA
Matthew 7:25 Inc dba Thrive Pharmacy recalls Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863
Hazard: Subpotent Drug
April 1, 2020DrugsFDA
Matthew 7:25 Inc dba Thrive Pharmacy recalls Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 28
Hazard: Subpotent Drug
April 1, 2020DrugsFDA
Grato Holdings, Inc. recalls Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Wood
Hazard: Labeling mix-up - Indications on product label are incorrect.
March 25, 2020DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Walth
Hazard: CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
March 25, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd
Hazard: CGMP Deviations: Presence of dark brown discoloration on edges of tablets
March 25, 2020DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51
Hazard: CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
March 25, 2020DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 5199
Hazard: CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
March 25, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limit
Hazard: Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
March 25, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, M
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
March 25, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, M
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
March 25, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, M
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
March 25, 2020DrugsFDA
Noven Therapeutics, LLC recalls Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, M
Hazard: Defective Delivery System: Out of specification for mechanical peel and shear.
March 25, 2020DrugsFDA
Med Man Distribution, Inc. recalls Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Man
Hazard: Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
March 25, 2020DrugsFDA
Med Man Distribution, Inc. recalls UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton,
Hazard: Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
March 25, 2020DrugsFDA
Par Pharmaceutical Inc. recalls PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977,
Hazard: Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
March 25, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 0
Hazard: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
March 25, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 0
Hazard: CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
March 25, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. ND
Hazard: Presence of particulate matter. presence of metal particles.
March 25, 2020DrugsFDA
RemedyRepack Inc. recalls Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0
Hazard: Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
March 25, 2020DrugsFDA
Strides Pharma Science Limited recalls Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Sh
Hazard: Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 011
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic C
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate:
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic C
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-3
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.