August 5, 2020DrugsFDA
MasterPharm LLC recalls Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-560
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 1
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill,
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle Mast
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866)
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-560
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
MasterPharm LLC recalls Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (86
Hazard: Lack of Processing Controls (lack of assurance of conformity to specifications).
August 5, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laborator
Hazard: Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
August 5, 2020DrugsFDA
POLARIZED LLC recalls Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbi
Hazard: CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
August 5, 2020DrugsFDA
WORLD EVENT PROMOTIONS, LLC recalls Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520
Hazard: Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
August 5, 2020DrugsFDA
Allergan PLC recalls Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Ac
Hazard: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
August 5, 2020DrugsFDA
Allergan PLC recalls Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, C
Hazard: SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
August 5, 2020DrugsFDA
UVT INC recalls Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbi
Hazard: Chemical Contamination: Product contains undeclared methanol.
July 29, 2020DrugsFDA
WALKER EMULSIONS INC recalls Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsion
Hazard: Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
July 29, 2020DrugsFDA
WALKER EMULSIONS INC recalls Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker
Hazard: Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
July 29, 2020DrugsFDA
Transliquid Technologies, LLC recalls Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra str
Hazard: Chemical Contamination: Presence of Undeclared Methanol
July 29, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceutical
Hazard: Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
July 29, 2020DrugsFDA
HF Acquisition Co. LLC recalls Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Dis
Hazard: TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.