December 21, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,
Hazard: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
December 21, 2022DrugsFDA
OurPharma LLC recalls FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repa
Hazard: Underfilled units.
December 14, 2022DrugsFDA
RemedyRepack Inc. recalls Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc.,
Hazard: Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
December 14, 2022DrugsFDA
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehe
Hazard: Lack of sterility assurance: Bags have the potential to leak.
December 14, 2022DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,
Hazard: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
December 7, 2022DrugsFDA
Acella Pharmaceuticals, LLC recalls Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,)
Hazard: Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
December 7, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Ta
Hazard: Failed dissolution specifications
December 7, 2022DrugsFDA
Heritage Pharmaceuticals Inc recalls Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick
Hazard: Subpotent Drug
December 7, 2022DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Ma
Hazard: Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
November 30, 2022DrugsFDA
Acella Pharmaceuticals, LLC recalls Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30
Hazard: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
November 30, 2022DrugsFDA
Acella Pharmaceuticals, LLC recalls Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10,
Hazard: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
November 30, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet
Hazard: Discoloration
November 23, 2022DrugsFDA
Adam's Polishes LLC recalls Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC
Hazard: CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
November 23, 2022DrugsFDA
Adam's Polishes LLC recalls Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC
Hazard: Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
November 23, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12
Hazard: CGMP Deviations: Potential for cross contamination due to product carry over.
November 23, 2022DrugsFDA
Nephron Sterile Compounding Center LLC recalls PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street E
Hazard: CGMP Deviations: Potential for cross contamination due to product carry over.
November 23, 2022DrugsFDA
Viatris Inc recalls Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made i
Hazard: Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
November 23, 2022DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 6
Hazard: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
November 23, 2022DrugsFDA
Par Formulations Private Limited recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridg
Hazard: Failed Impurities/Degradation Specifications
November 23, 2022DrugsFDA
ImprimisRx NJ recalls Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Hazard: Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
November 23, 2022DrugsFDA
Aadi Bioscience recalls Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50,
Hazard: Failed Stability Specifications
November 16, 2022DrugsFDA
Viatris Inc recalls Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use
Hazard: Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesb
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesbu
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg,
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 1
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Ha
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hatties
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
November 9, 2022DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesb
Hazard: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.