Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1733-2019 | 07-11-2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-03, UPC 3 11917 18245 2 . Package NDCs: 0363-0638-01; 0363-0638-03 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 305 cases | Class II | Terminated |
| D-1728-2019 | 07-11-2019 | Adult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25, Package NDCs: 0363-0445-25 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 98 cases | Class II | Terminated |
| D-1734-2019 | 07-11-2019 | Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6 Package NDCs: 0363-0638-02; 0363-0638-04 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 651 cases | Class II | Terminated |
| D-1735-2019 | 07-11-2019 | Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 830 tubes | Class II | Terminated |
| D-1517-2019 | 07-11-2019 | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. Package NDCs: 27808-086-02; 27808-086-01; 27808-086-03 | Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives. | Tris Pharma Inc. / 2,550 bottles | Class II | Terminated |
| D-1732-2019 | 07-11-2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6 Package NDCs: 0363-0620-02; 0363-0620-04 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 1223 cases | Class II | Terminated |
| D-1731-2019 | 07-11-2019 | Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3 Package NDCs: 0363-0620-01; 0363-0620-03 | CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process. | US Pharmaceuticals Inc. / 3114 cases | Class II | Terminated |
| D-1630-2019 | 07-10-2019 | Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1 Package NDCs: 49035-330-45; 49035-330-02; 49035-330-96; 8113117595 | Microbial contamination of non-sterile product | LNK International, Inc. / P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter | Class II | Terminated |
| D-1487-2019 | 07-09-2019 | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233. | Lack of Assurance of Sterility: Bags have the potential to leak. | Pfizer Inc. / 280340 bags | Class II | Terminated |
| D-1486-2019 | 07-09-2019 | Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028. | Lack of Assurance of Sterility: Bags have the potential to leak. | Pfizer Inc. / 58200 bags | Class II | Terminated |
| D-1837-2019 | 07-09-2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43 | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. / 11,412 cartons/34,236 blister cards/28 tablets each card | Class I | Terminated |
| D-1742-2019 | 07-08-2019 | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01 Package NDCs: 66794-151-01; 66794-155-01; 66794-155-02; 66794-156-01; 66794-156-02; 66794-157-01; 66794-157-02 | Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product. | Piramal Critical Care, Inc. / Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes) | Class II | Terminated |
| D-0355-2020 | 07-02-2019 | Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 261,528 units | Class II | Completed |
| D-0357-2020 | 07-02-2019 | Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 41148 units | Class II | Completed |
| D-0362-2020 | 07-02-2019 | Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road Deerfield IL 60015 NDC 0363-0193-13 Package NDCs: 0363-0193-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 43008 units | Class II | Completed |
| D-0361-2020 | 07-02-2019 | Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g), Distributed by Walgreen Co. 200 Wilmot Road Deerfield, IL 60015, NDC 0363-7500-50 Package NDCs: 0363-7500-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 30240 units | Class II | Completed |
| D-0353-2020 | 07-02-2019 | Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 121572 containers | Class II | Completed |
| D-0416-2020 | 07-02-2019 | ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire Pharmaceuticals Inc. Aquebogue, NY 11931, NDC 59390-184-50 Package NDCs: 59390-184-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 46345 units | Class II | Completed |
| D-0356-2020 | 07-02-2019 | Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 651528 units | Class II | Completed |
| D-0354-2020 | 07-02-2019 | Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 87922 containers | Class II | Completed |
| D-0352-2020 | 07-02-2019 | Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 1737549 containers | Class II | Completed |
| D-0415-2020 | 07-02-2019 | Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 306,479 units | Class II | Completed |
| D-0467-2020 | 07-02-2019 | Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 20666 units | Class II | Completed |
| D-0440-2020 | 07-02-2019 | OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 81403 units | Class II | Completed |
| D-0376-2020 | 07-02-2019 | CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 531,936 units | Class II | Completed |
| D-0434-2020 | 07-02-2019 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 4409 units | Class II | Completed |
| D-0396-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 222096 units | Class II | Completed |
| D-0427-2020 | 07-02-2019 | iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 137 units | Class II | Completed |
| D-0443-2020 | 07-02-2019 | OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 9518 units | Class II | Completed |
| D-0489-2020 | 07-02-2019 | Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0365-2020 | 07-02-2019 | Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 441792 units | Class II | Completed |
| D-0456-2020 | 07-02-2019 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0442-2020 | 07-02-2019 | OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 75996 units | Class II | Completed |
| D-0379-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 114,504 units | Class II | Completed |
| D-0483-2020 | 07-02-2019 | FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 31070 units | Class II | Completed |
| D-0464-2020 | 07-02-2019 | Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 84216 units | Class II | Completed |
| D-0423-2020 | 07-02-2019 | Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48,542 units | Class II | Completed |
| D-0430-2020 | 07-02-2019 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 24 units | Class II | Completed |
| D-0359-2020 | 07-02-2019 | Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, Item #801483 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 35,896 units | Class II | Completed |
| D-0468-2020 | 07-02-2019 | TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0474-2020 | 07-02-2019 | Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 195,864 units | Class II | Completed |
| D-0451-2020 | 07-02-2019 | OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 29326 units | Class II | Completed |
| D-0407-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 66,159 units | Class II | Completed |
| D-0455-2020 | 07-02-2019 | Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05 Package NDCs: 59390-192-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 23974 units | Class II | Completed |
| D-0411-2020 | 07-02-2019 | CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 464,424 units | Class II | Completed |
| D-0436-2020 | 07-02-2019 | Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05 Package NDCs: 59390-140-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 102,939 units | Class II | Completed |
| D-0447-2020 | 07-02-2019 | OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 55,134 units | Class II | Completed |
| D-0425-2020 | 07-02-2019 | Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 809,600 units | Class II | Completed |
| D-0422-2020 | 07-02-2019 | Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-205-05 Package NDCs: 59390-205-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 532,961 units | Class II | Completed |
| D-0486-2020 | 07-02-2019 | Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0395-2020 | 07-02-2019 | CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0419-2020 | 07-02-2019 | Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire Pharmaceuticals, Inc Aquebogue, NY 11931 NDC 59390-217-02 Package NDCs: 59390-217-02; 59390-217-05; 59390-217-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 3060 units | Class II | Completed |
| D-0466-2020 | 07-02-2019 | Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 61830 units | Class II | Completed |
| D-0487-2020 | 07-02-2019 | Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0426-2020 | 07-02-2019 | Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13 Package NDCs: 59390-182-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 202266 units | Class II | Completed |
| D-0461-2020 | 07-02-2019 | Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05 Package NDCs: 59390-149-02; 59390-149-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 49527 units | Class II | Completed |
| D-0375-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 100,680 units | Class II | Completed |
| D-0432-2020 | 07-02-2019 | Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 13,375 units | Class II | Completed |
| D-0446-2020 | 07-02-2019 | OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 105609 units | Class II | Completed |
| D-0413-2020 | 07-02-2019 | CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 24,024 units | Class II | Completed |
| D-0417-2020 | 07-02-2019 | ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13 Package NDCs: 59390-183-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 22494 units | Class II | Completed |
| D-0429-2020 | 07-02-2019 | iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 13,407 units | Class II | Completed |
| D-0389-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 77,760 units | Class II | Completed |
| D-0374-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 365,832 units | Class II | Completed |
| D-0391-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48,168 units | Class II | Completed |
| D-0454-2020 | 07-02-2019 | CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 50,304 units | Class II | Completed |
| D-0448-2020 | 07-02-2019 | OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 296,314 units | Class II | Completed |
| D-0358-2020 | 07-02-2019 | Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 195,864 unts | Class II | Completed |
| D-0438-2020 | 07-02-2019 | ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 47 units | Class II | Completed |
| D-0366-2020 | 07-02-2019 | Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 469128 units | Class II | Completed |
| D-0392-2020 | 07-02-2019 | CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 483528 units | Class II | Completed |
| D-0435-2020 | 07-02-2019 | iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 12,716 units | Class II | Completed |
| D-0450-2020 | 07-02-2019 | OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 81217 units | Class II | Completed |
| D-0463-2020 | 07-02-2019 | Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 41925 units | Class II | Completed |
| D-0420-2020 | 07-02-2019 | Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10 Package NDCs: 59390-217-02; 59390-217-05; 59390-217-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 636 units | Class II | Completed |
| D-0387-2020 | 07-02-2019 | CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 238,968 units | Class II | Completed |
| D-0405-2020 | 07-02-2019 | CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 58,704 units | Class II | Completed |
| D-0401-2020 | 07-02-2019 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0459-2020 | 07-02-2019 | Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 73,548 units | Class II | Completed |
| D-0472-2020 | 07-02-2019 | Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0403-2020 | 07-02-2019 | CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 39,744 units | Class II | Completed |
| D-0478-2020 | 07-02-2019 | Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05 Package NDCs: 59390-217-02; 59390-217-05; 59390-217-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 6024 units | Class II | Completed |
| D-0418-2020 | 07-02-2019 | ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50 Package NDCs: 59390-198-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 161077 units | Class II | Completed |
| D-0404-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48,168 units | Class II | Completed |
| D-0380-2020 | 07-02-2019 | CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 39,288 units | Class II | Completed |
| D-0385-2020 | 07-02-2019 | CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0363-2020 | 07-02-2019 | Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 45672 units | Class II | Completed |
| D-0414-2020 | 07-02-2019 | iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 6,877 units | Class II | Completed |
| D-0479-2020 | 07-02-2019 | Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 2870 units | Class II | Completed |
| D-0424-2020 | 07-02-2019 | Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 414,346 units | Class II | Completed |
| D-0453-2020 | 07-02-2019 | OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 13626 units | Class II | Completed |
| D-0394-2020 | 07-02-2019 | CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0398-2020 | 07-02-2019 | Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 139572 units | Class II | Completed |
| D-0437-2020 | 07-02-2019 | ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-148-52 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 88 units | Class II | Completed |
| D-0441-2020 | 07-02-2019 | Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 88,008 units | Class II | Completed |
| D-0370-2020 | 07-02-2019 | Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 99420 units | Class II | Completed |
| D-0421-2020 | 07-02-2019 | Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02 Package NDCs: 59390-149-02; 59390-149-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 390 units | Class II | Completed |
| D-0367-2020 | 07-02-2019 | Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 1537130 units | Class II | Completed |
| D-0406-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 39,072 units | Class II | Completed |
| D-0445-2020 | 07-02-2019 | OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 14091 cartons. | Class II | Completed |
