February 28, 2024DrugsFDA
Henry Schein Inc. and Glove Club HSI Gloves Inc. recalls Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
February 28, 2024DrugsFDA
Mallinckrodt Hospital Products Inc. recalls Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Pro
Hazard: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
February 28, 2024DrugsFDA
Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mf
Hazard: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
February 28, 2024DrugsFDA
Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,
Hazard: Failed Impurities/Degradation Specification: Out of specification for organic impurities
February 28, 2024DrugsFDA
Alpha Aromatics recalls Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Par
Hazard: CGMP Deviations
February 28, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bott
Hazard: Labeling: Incorrect or Missing Package Insert
February 28, 2024DrugsFDA
Baxter Healthcare Corporation recalls Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial
Hazard: Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
February 28, 2024DrugsFDA
Neptune Resources, LLC recalls Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Dist
Hazard: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
February 28, 2024DrugsFDA
Neptune Resources, LLC recalls Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N
Hazard: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
February 28, 2024DrugsFDA
Neptune Resources, LLC recalls Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N.
Hazard: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
February 28, 2024DrugsFDA
Bestco LLC recalls Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160
Hazard: CGMP Deviations: Potential Glass and Silicone particulates in product
February 28, 2024DrugsFDA
Bestco LLC recalls Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Be
Hazard: CGMP Deviations: Potential Glass and Silicone particulates in product
February 28, 2024DrugsFDA
Bestco LLC recalls Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 2
Hazard: CGMP Deviations: Potential Glass and Silicone particulates in product
February 28, 2024DrugsFDA
Bestco LLC recalls Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 2
Hazard: CGMP Deviations: Potential Glass and Silicone particulates in product
February 28, 2024DrugsFDA
Bestco LLC recalls CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestc
Hazard: CGMP Deviations: Potential Glass and Silicone particulates in product
February 28, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceu
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification test results.
February 28, 2024DrugsFDA
Apotex Corp. recalls Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc
Hazard: CGMP Deviations: potential presence of Burkholderia cepacia complex
February 21, 2024DrugsFDA
IntegraDose Compounding Services LLC recalls Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe,
Hazard: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
February 21, 2024DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactu
Hazard: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
February 21, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton con
Hazard: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
February 21, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister ca
Hazard: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
February 14, 2024DrugsFDA
Amerisource Health Services LLC recalls HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: Americ
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
February 14, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
February 14, 2024DrugsFDA
NATCO Pharma Limited recalls Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228
Hazard: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
February 14, 2024DrugsFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured
Hazard: Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
February 14, 2024DrugsFDA
Amerisource Health Services LLC recalls Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus,
Hazard: CGMP Deviations
February 14, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409
Hazard: Misprint on tablet
February 14, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409
Hazard: Misprint on tablet
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distrib
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles
Hazard: Non-Sterility