August 9, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue
Hazard: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc.
Hazard: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
August 9, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix
Hazard: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
August 9, 2023DrugsFDA
The Ritedose Corporation recalls Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not
Hazard: CGMP deviation: product released prior to supplier approval.
August 2, 2023DrugsFDA
SCA Pharmaceuticals recalls FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL C
Hazard: cGMP deviations: due to shipment of rejected units.
August 2, 2023DrugsFDA
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only
Hazard: Lack of Assurance of Sterility
August 2, 2023DrugsFDA
Kramer Laboratories, Inc. recalls Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer L
Hazard: CGMP Deviations: use of non-food grade lubricant in mixing vessel.
August 2, 2023DrugsFDA
Kramer Laboratories, Inc. recalls Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4
Hazard: CGMP Deviations: use of non-food grade lubricant in mixing vessel.
August 2, 2023DrugsFDA
ALEMBIC PHARMACEUTICALS, INC. recalls Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharm
Hazard: Defective Delivery System
August 2, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc.
Hazard: Presence of Foreign Substance: Metal embedded in a tablet.
August 2, 2023DrugsFDA
Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC
Hazard: Lack of Assurance of Sterility
August 2, 2023DrugsFDA
Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplu
Hazard: Lack of Assurance of Sterility
August 2, 2023DrugsFDA
Sagent Pharmaceuticals recalls Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, I
Hazard: Lack of Assurance of Sterility
July 26, 2023DrugsFDA
Glenmark Therapeutics, Inc. recalls Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwa
Hazard: Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
July 26, 2023DrugsFDA
SterRx, LLC recalls Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 1
Hazard: Lack of Assurance of Sterility
July 26, 2023DrugsFDA
SterRx, LLC recalls Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12
Hazard: Lack of Assurance of Sterility
July 26, 2023DrugsFDA
SterRx, LLC recalls Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12
Hazard: Lack of Assurance of Sterility
July 26, 2023DrugsFDA
SterRx, LLC recalls Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12
Hazard: Lack of Assurance of Sterility
July 26, 2023DrugsFDA
SterRx, LLC recalls Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged i
Hazard: Lack of Assurance of Sterility
July 26, 2023DrugsFDA
New England Life Care, Inc. dba Advanced Compounding Solutions recalls Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compoundi
Hazard: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
July 26, 2023DrugsFDA
New England Life Care, Inc. dba Advanced Compounding Solutions recalls ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste
Hazard: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
July 26, 2023DrugsFDA
New England Life Care, Inc. dba Advanced Compounding Solutions recalls PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compoundi
Hazard: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
July 26, 2023DrugsFDA
New England Life Care, Inc. dba Advanced Compounding Solutions recalls SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constituti
Hazard: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
July 26, 2023DrugsFDA
Ascend Laboratories, LLC recalls Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by:
Hazard: Failed Dissolution Specifications
July 26, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#
Hazard: Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
July 26, 2023DrugsFDA
Dr Reddy's Laboratories Limited recalls Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam -
Hazard: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
July 19, 2023DrugsFDA
Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx o
Hazard: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
July 19, 2023DrugsFDA
Global Pharma Healthcare Private Limited recalls Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 m
Hazard: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
July 19, 2023DrugsFDA
Global Pharma Healthcare Private Limited recalls Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 m
Hazard: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
July 19, 2023DrugsFDA
Global Pharma Healthcare Private Limited recalls Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distribut
Hazard: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.