June 19, 2024DrugsFDA
Organon Llc recalls Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for:
Hazard: Defective Container
June 19, 2024DrugsFDA
Organon Llc recalls Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for:
Hazard: Defective Container
June 19, 2024DrugsFDA
Organon Llc recalls Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for:
Hazard: Defective Container
June 19, 2024DrugsFDA
RemedyRepack Inc. recalls Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518
Hazard: Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
June 19, 2024DrugsFDA
Imprimis NJOF, LLC recalls Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compo
Hazard: Lack of Assurance of Sterility
June 19, 2024DrugsFDA
Imprimis NJOF, LLC recalls Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. N
Hazard: Lack of Assurance of Sterility
June 19, 2024DrugsFDA
PACIRA PHARMACEUTICALS INC recalls Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Ma
Hazard: Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
June 19, 2024DrugsFDA
Winder Laboratories, LLC recalls Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patr
Hazard: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
June 12, 2024DrugsFDA
GlaxoSmithKline LLC recalls Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton contains one bottle of 60 table
Hazard: Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
June 12, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmed
Hazard: Failed Impurities/Degradation Specifications.
June 12, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahme
Hazard: Failed Impurities/Degradation Specifications.
June 12, 2024DrugsFDA
Rising Pharma Holding, Inc. recalls Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ
Hazard: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
June 12, 2024DrugsFDA
Bryant Ranch Prepack, Inc. recalls Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP e
Hazard: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
June 12, 2024DrugsFDA
Bryant Ranch Prepack, Inc. recalls Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, U
Hazard: Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
June 12, 2024DrugsFDA
Bryant Ranch Prepack, Inc. recalls Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP
Hazard: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
June 12, 2024DrugsFDA
Bryant Ranch Prepack, Inc. recalls Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate,
Hazard: Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
June 12, 2024DrugsFDA
Bryant Ranch Prepack, Inc. recalls Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burba
Hazard: Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark P
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Ph
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc.,
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 12, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., US
Hazard: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
June 5, 2024DrugsFDA
Regeneron Pharmaceuticals Inc recalls EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled
Hazard: Lack of Assurance of Sterility: Complaints of syringe breakage
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum P
Hazard: Out of Specification for active ingredient
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MS
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MS
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor,
Hazard: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
June 5, 2024DrugsFDA
ARG Laboratories, Inc. recalls ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40
Hazard: Out of Specification for active ingredient