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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0485-2020 | 07-02-2019 | Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 73548 units | Class II | Completed |
| D-0476-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 114504 units | Class II | Completed |
| D-0477-2020 | 07-02-2019 | CVS Health Multi-Action Relief Drops, Item#: 694954, 15 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-0360-2020 | 07-02-2019 | Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0469-2020 | 07-02-2019 | TRP Blur Relief, 15 mL, NDC 17312-002-11 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 24144 units | Class II | Completed |
| D-0372-2020 | 07-02-2019 | Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.) | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 17,613 units | Class II | Completed |
| D-0490-2020 | 07-02-2019 | Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0369-2020 | 07-02-2019 | Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 259104 units | Class II | Completed |
| D-0383-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 39072 units | Class II | Completed |
| D-0428-2020 | 07-02-2019 | iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 2,392 units | Class II | Completed |
| D-0388-2020 | 07-02-2019 | CVS Health Preservative Free 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-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 |
| D-0458-2020 | 07-02-2019 | Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 90072 units | Class II | Completed |
| D-0481-2020 | 07-02-2019 | OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 19632 units | Class II | Completed |
| D-0433-2020 | 07-02-2019 | Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 1,666 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-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-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-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-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-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-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-0410-2020 | 07-02-2019 | CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz., (15 mL), Item #994880, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 483,528 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-0473-2020 | 07-02-2019 | Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-35 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 273,100 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-0409-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, 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. / 37656 units | Class II | Completed |
| D-0412-2020 | 07-02-2019 | CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 222,096 units | Class II | Completed |
| D-0482-2020 | 07-02-2019 | OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | 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-0444-2020 | 07-02-2019 | OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 103856 units | Class II | Completed |
| D-0371-2020 | 07-02-2019 | Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 50,904 units | Class II | Completed |
| D-0382-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 45864 units | Class II | Completed |
| D-0480-2020 | 07-02-2019 | Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0462-2020 | 07-02-2019 | Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 81969 units | Class II | Completed |
| D-0475-2020 | 07-02-2019 | Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0364-2020 | 07-02-2019 | Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 557,376 units | Class II | Completed |
| D-0457-2020 | 07-02-2019 | Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 90,072 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-0452-2020 | 07-02-2019 | OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 19632 units | Class II | Completed |
| D-0471-2020 | 07-02-2019 | TRP Pink Eye Relief, 10 mL, NDC 17312-013-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 1,381,638 units | 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-0384-2020 | 07-02-2019 | CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 284,232 units | Class II | Completed |
| D-0393-2020 | 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. / 464424 units | 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-0378-2020 | 07-02-2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 31010 6 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 45,864 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-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-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-0465-2020 | 07-02-2019 | Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 41906 units | 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-0439-2020 | 07-02-2019 | ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48 units | Class II | Completed |
| D-0431-2020 | 07-02-2019 | iSolutions Nano Tears MXP Forte 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 59390-147-56 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 48,973 units | Class II | Completed |
| D-0397-2020 | 07-02-2019 | Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / N/A | Class II | Completed |
| D-0377-2020 | 07-02-2019 | CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 101,712 units | Class II | Completed |
| D-0381-2020 | 07-02-2019 | CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 02895 Made in the USA | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 101712 units | Class II | Completed |
| D-0373-2020 | 07-02-2019 | CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 152,369 units | Class II | Completed |
| D-0402-2020 | 07-02-2019 | CVS Health Extra Strength Lubricant Gel 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. / 159864 units | Class II | Completed |
| D-0399-2020 | 07-02-2019 | Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 2,042,136 units | 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 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 202266 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-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 | Lack of Assurance of Sterility | Altaire Pharmaceuticals, Inc. / 23974 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-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-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-1565-2019 | 07-02-2019 | Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets) | Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study. | Lupin Pharmaceuticals Inc. / 12938 units | Class II | Terminated |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1489-2019 | 06-28-2019 | Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand] Package NDCs: 63323-117-51; 63323-117-61; 63323-117-59; 63323-117-69 | Presence of Particulate Matter; glass particulates | Fresenius Kabi USA, LLC / 14,016 vials | Class I | Terminated |
| D-1474-2019 | 06-26-2019 | Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 50 mL | Class II | Terminated |
| D-1472-2019 | 06-26-2019 | Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252. | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 12 mL | Class II | Terminated |
| D-1476-2019 | 06-26-2019 | Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 60 mL | Class II | Terminated |
| D-1477-2019 | 06-26-2019 | Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 8 mL | Class II | Terminated |
| D-1473-2019 | 06-26-2019 | Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252. | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 3 mL | Class II | Terminated |
| D-1483-2019 | 06-26-2019 | Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 8 mL | Class II | Terminated |
| D-1469-2019 | 06-26-2019 | Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252. | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 12 mL | Class II | Terminated |
| D-1475-2019 | 06-26-2019 | Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205 (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / a) 2.5 mL b) 10 mL | Class II | Terminated |
| D-1481-2019 | 06-26-2019 | PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 5 mL | Class II | Terminated |
| D-1482-2019 | 06-26-2019 | PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252 | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy / 5 mL | Class II | Terminated |
