May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg
Hazard: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
May 31, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, I
Hazard: Lack of Assurance of Sterility
May 31, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25
Hazard: Lack of Assurance of Sterility
May 31, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25
Hazard: Lack of Assurance of Sterility
May 31, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceuti
Hazard: Failed Dissolution Specifications; during stability testing
May 31, 2023DrugsFDA
Alpha Aromatics recalls FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Pa
Hazard: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
May 31, 2023DrugsFDA
Amerisource Health Services LLC recalls Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
May 31, 2023DrugsFDA
Amerisource Health Services LLC recalls Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 6800
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
May 31, 2023DrugsFDA
Amerisource Health Services LLC recalls Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-1
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
May 31, 2023DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injecti
Hazard: Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 1
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Al
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Ro
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, A
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Ce
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Ph
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Ph
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Phar
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharm
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharm
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Serv
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100,
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
May 31, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snow
Hazard: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.