Drug Recall
Terminated
Historical recordClass III
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
by VistaPharm, Inc.
- Reason
- Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
- Recall initiated
- June 23, 2020
- Reported by FDA
- July 15, 2020
- Distribution
- United States including Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
- Recall initiated
- June 4, 2020
- Reported by FDA
- July 15, 2020
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
- Recall initiated
- June 4, 2020
- Reported by FDA
- July 15, 2020
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
- Recall initiated
- June 4, 2020
- Reported by FDA
- July 15, 2020
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
by Flexion Therapeutics, Inc.
- Reason
- Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
- Recall initiated
- May 19, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide within the United States only lots distributed by Besse Medical are affected.
View recall →
Drug Recall
Terminated
Historical recordClass II
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Recall initiated
- June 17, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Product was distributed to two medical clinics located in FL.
View recall →
Drug Recall
Terminated
Historical recordClass I
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
by MasterPharm LLC
- Reason
- Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
- Recall initiated
- June 9, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- FL and MD
View recall →
Drug Recall
Terminated
Historical recordClass II
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
- Recall initiated
- June 16, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide in the US
View recall →
Drug Recall
Terminated
Historical recordClass II
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
- Recall initiated
- June 16, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide in the US
View recall →
Drug Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
by The Harvard Drug Group
- Reason
- CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
- Recall initiated
- June 12, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Recall initiated
- June 12, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Recall initiated
- June 12, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Recall initiated
- June 12, 2020
- Reported by FDA
- July 8, 2020
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Recall initiated
- May 29, 2020
- Reported by FDA
- July 1, 2020
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
by American Health Packaging
- Reason
- Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
- Recall initiated
- June 10, 2020
- Reported by FDA
- July 1, 2020
- Distribution
- Nationwide USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
by Aurobindo Pharma USA Inc.
- Reason
- Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
- Recall initiated
- June 12, 2020
- Reported by FDA
- July 1, 2020
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
by Rising Pharmaceuticals, Inc.
- Reason
- Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
- Recall initiated
- November 15, 2019
- Reported by FDA
- July 1, 2020
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05
by Rising Pharmaceuticals, Inc.
- Reason
- Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
- Recall initiated
- November 15, 2019
- Reported by FDA
- July 1, 2020
- Distribution
- U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
by Marksans Pharma Limited
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Recall initiated
- June 5, 2020
- Reported by FDA
- July 1, 2020
- Distribution
- Nationwide
View recall →
Drug Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Recall initiated
- May 29, 2020
- Reported by FDA
- July 1, 2020
- Distribution
- Nationwide
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
