January 5, 2022DrugsFDA
SterRx, LLC recalls Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsbur
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Platts
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Platt
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Platts
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Platts
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Platt
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plat
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsb
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsbu
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, N
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Platts
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue,
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh,
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
Gilead Sciences, Inc. recalls Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos
Hazard: Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
January 5, 2022DrugsFDA
Aroma Release Technologies Inc recalls Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Techn
Hazard: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
January 5, 2022DrugsFDA
Teligent Pharma, Inc. recalls Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, N
Hazard: Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
January 5, 2022DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured
Hazard: Superpotent Drug: Minimally superpotent
January 5, 2022DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured
Hazard: Superpotent Drug
December 29, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (N
Hazard: Subpotent
December 29, 2021DrugsFDA
Efficient Laboratories, Inc. recalls Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc
Hazard: Microbial Contamination of Non-Sterile Products
December 29, 2021DrugsFDA
Efficient Laboratories, Inc. recalls Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottle
Hazard: Microbial Contamination of Non-Sterile Products
December 29, 2021DrugsFDA
Efficient Laboratories, Inc. recalls Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Hazard: Microbial Contamination of Non-Sterile Products
December 29, 2021DrugsFDA
Efficient Laboratories, Inc. recalls Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Mi
Hazard: Microbial Contamination of Non-Sterile Products
December 29, 2021DrugsFDA
The Harvard Drug Group recalls Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laure
Hazard: Failed Impurities/Degradation Specifications
December 29, 2021DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Com
Hazard: Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
December 29, 2021DrugsFDA
Medline Industries Inc recalls Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC
Hazard: Defective Container: Customer complaints for leaking bottles and dispensing issues.
December 22, 2021DrugsFDA
Torrent Pharma Inc. recalls Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Ph
Hazard: Superpotent; Hydrochlorothiazide
December 22, 2021DrugsFDA
Valgene Incorporated dba Cape Drugs recalls B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Hazard: Lack of Processing Controls
December 22, 2021DrugsFDA
Valgene Incorporated dba Cape Drugs recalls Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Hazard: Lack of Processing Controls
December 22, 2021DrugsFDA
TOLMAR, Inc. recalls Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263
Hazard: Superpotent Drug