November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
November 3, 2021DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
October 27, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Ma
Hazard: Out of specification result observed in a dissolution test at the 9-month long term stability time point.
October 27, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules pe
Hazard: CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
October 27, 2021DrugsFDA
Teva Pharmaceuticals USA recalls AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva
Hazard: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
October 27, 2021DrugsFDA
Teva Pharmaceuticals USA recalls AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Tev
Hazard: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
October 27, 2021DrugsFDA
Teva Pharmaceuticals USA recalls AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva R
Hazard: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
October 27, 2021DrugsFDA
Teva Pharmaceuticals USA recalls AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale,
Hazard: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
October 27, 2021DrugsFDA
Teva Pharmaceuticals USA recalls AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, R
Hazard: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
October 27, 2021DrugsFDA
American Health Packaging recalls GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx o
Hazard: Failed Dissolution Specifications: results were above specification.
October 27, 2021DrugsFDA
Piramal Critical Care, Inc. recalls Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem
Hazard: Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
October 27, 2021DrugsFDA
Sanitor Corporation recalls Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC
Hazard: CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc
Hazard: cGMP Deviations
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc
Hazard: cGMP Deviations
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wi
Hazard: cGMP Deviations
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1
Hazard: Chemical contamination; presence of benzene
October 27, 2021DrugsFDA
Beiersdorf Inc recalls Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wi
Hazard: Chemical contamination; presence of benzene