October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services,
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 921
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, S
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, S
Hazard: Lack of assurance of sterility:
October 11, 2023DrugsFDA
Central Admixture Pharmacy Services Inc recalls fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services,
Hazard: Lack of assurance of sterility:
October 4, 2023DrugsFDA
RB Health (US) LLC recalls Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in ca
Hazard: Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
October 4, 2023DrugsFDA
Tolmar, Inc. recalls Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted befo
Hazard: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
October 4, 2023DrugsFDA
Sofie Co dba Sofie recalls Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intr
Hazard: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
September 27, 2023DrugsFDA
HUMANRACE recalls Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle,
Hazard: Subpotent Drug: Product does not contain SPF that is declared on the label.
September 27, 2023DrugsFDA
HUMANRACE recalls Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl
Hazard: Subpotent Drug: Product does not contain SPF that is declared on the label.
September 27, 2023DrugsFDA
Novartis Pharmaceuticals Corp. recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM
Hazard: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
September 27, 2023DrugsFDA
Vi-Jon, LLC recalls Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate
Hazard: Incorrect/Undeclared Excipients.
September 27, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx
Hazard: Subpotent: Out of Specification result observed for low assay
September 27, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127
Hazard: Failed dissolution specifications - results obtained were below spec average.
September 27, 2023DrugsFDA
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (
Hazard: Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Inno
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclus
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusi
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusivel
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMA
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusivel
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusive
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv
Hazard: Lack of Assurance of Sterility