PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810...
Reason: Lack of Assurance of Sterility
D-0415-2024April 3, 2024Windsor, CT
Optikem International, Inc.
Class IIOngoing
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
Reason: Lack of Assurance of Sterility
D-0383-2024March 20, 2024Denver, CO
Optikem International, Inc.
Class IIOngoing
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Reason: Lack of Assurance of Sterility
D-0377-2024March 20, 2024Denver, CO
Optikem International, Inc.
Class IIOngoing
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
Reason: Lack of Assurance of Sterility
D-0375-2024March 20, 2024Denver, CO
B. Braun Medical Inc
Class IITerminated
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Reason: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
D-0370-2024March 20, 2024Irvine, CA
Optikem International, Inc.
Class IIOngoing
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Reason: Lack of Assurance of Sterility
D-0379-2024March 20, 2024Denver, CO
Optikem International, Inc.
Class IIOngoing
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Reason: Lack of Assurance of Sterility
D-0376-2024March 20, 2024Denver, CO
Optikem International, Inc.
Class IIOngoing
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
Reason: Lack of Assurance of Sterility
D-0384-2024March 20, 2024Denver, CO
Thea Pharma, Inc.
Class IITerminated
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Reason: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
D-0374-2024March 20, 2024Waltham, MA
Optikem International, Inc.
Class IIOngoing
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
Reason: Lack of Assurance of Sterility
D-0351-2024March 6, 2024Thane
Brassica Pharma Pvt Ltd
Class IIOngoing
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Reason: Lack of Assurance of Sterility
D-0352-2024March 6, 2024Thane
Brassica Pharma Pvt Ltd
Class IIOngoing
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895...
Reason: Lack of Assurance of Sterility
D-0353-2024March 6, 2024Thane
Brassica Pharma Pvt Ltd
Class IIOngoing
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356