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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0368-2020	07-02-2019	Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size: 3.5g and 15mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-883-59	Lack of Assurance of Sterility	Altaire Pharmaceuticals, Inc. / 55772 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-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-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-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-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-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-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-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-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-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-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-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-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-0470-2020	07-02-2019	TRP Stye Relief, 4 g, NDC 17312-014-13	Lack of Assurance of Sterility	Altaire Pharmaceuticals, Inc. / 318,412 units	Class II	Completed
D-0449-2020	07-02-2019	OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21	Lack of Assurance of Sterility	Altaire Pharmaceuticals, Inc. / 427,280 units	Class II	Completed
D-0390-2020	07-02-2019	CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Altaire Pharmaceuticals, Inc. / 109,020 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-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-0386-2020	07-02-2019	CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895	Lack of Assurance of Sterility	Altaire Pharmaceuticals, Inc. / 159,864 units	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-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-1480-2019	06-26-2019	PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL 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 / 10 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-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-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
D-1470-2019	06-26-2019	Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, 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) 18 mL b) 12mL	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-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-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-1479-2019	06-26-2019	PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL 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
D-1471-2019	06-26-2019	Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL 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) 14.4 mL, b) 9.6 mL, c) 10.8 mL	Class II	Terminated
D-1468-2019	06-26-2019	Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL 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 / 24 mL	Class II	Terminated
D-1484-2019	06-26-2019	Glutathione 100 mg/mL Inhalation Solution (PF), 45 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 / 45 mL	Class II	Terminated
D-1478-2019	06-26-2019	Methylcobalamin 10 mg/mL Injection, 5.4 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 / 5.4 mL	Class II	Terminated
D-1485-2019	06-26-2019	Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, 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) 60 EA, b) 15mL, c) 24 EA	Class II	Terminated
D-1585-2019	06-25-2019	Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179	Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.	AAA Pharmaceutical, Inc. / a) 288 bottles b) 48 bottles	Class III	Terminated
D-1429-2019	06-24-2019	Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04	Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).	H J Harkins Company Inc dba Pharma Pac / 40 bottles	Class II	Terminated
D-1430-2019	06-24-2019	Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.	Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).	H J Harkins Company Inc dba Pharma Pac / 12 bottles	Class II	Terminated
D-1501-2019	06-21-2019	Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 1070 jars	Class II	Terminated
D-1496-2019	06-21-2019	ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 1508 jars	Class II	Terminated
D-1500-2019	06-21-2019	Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 1032 jars	Class II	Terminated
D-1506-2019	06-21-2019	NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 2052 bottles	Class II	Terminated
D-1494-2019	06-21-2019	ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 4981 roll on bottles	Class II	Terminated
D-1503-2019	06-21-2019	Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 1000 jars	Class II	Terminated
D-1492-2019	06-21-2019	Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 998 bottles	Class II	Terminated
D-1507-2019	06-21-2019	Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 5273 roll on bottles	Class II	Terminated
D-1499-2019	06-21-2019	LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 2000 roll on bottles	Class II	Terminated
D-1502-2019	06-21-2019	Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 310 roll on bottles	Class II	Terminated
D-1498-2019	06-21-2019	DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 500 bottles	Class II	Terminated
D-1493-2019	06-21-2019	AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 19422 jars	Class II	Terminated
D-1495-2019	06-21-2019	Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 1000 bottles	Class II	Terminated
D-1497-2019	06-21-2019	GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16. Package NDCs: 52083-650-16	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 3000 bottles	Class II	Terminated
D-1504-2019	06-21-2019	TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 8340 bottles	Class II	Terminated
D-1505-2019	06-21-2019	SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16. Package NDCs: 52083-660-16	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.	Pharma-Natural Inc. / 7392 bottles	Class II	Terminated
D-1457-2019	06-20-2019	Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10 Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Macleods Pharma Usa Inc / 47520 bottles (4,276,800 tablets)	Class II	Terminated
D-1458-2019	06-20-2019	Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44 Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Macleods Pharma Usa Inc / 4277 bottles (4,277,000 tablets)	Class II	Terminated
D-1460-2019	06-20-2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Macleods Pharma Usa Inc / 29106 bottles (2,619,540 tablets)	Class II	Terminated
D-1459-2019	06-20-2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Macleods Pharma Usa Inc / 142626 bottles (12,836,340 tablets)	Class II	Terminated
D-1461-2019	06-20-2019	Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.	Macleods Pharma Usa Inc / 145162 bottles (13,064,580 tablets)	Class II	Terminated
D-1717-2019	06-19-2019	VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 2 ML Vial: 70731-0961-02; NDC 30 ML Vial: 70731-0961-30	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1657-2019	06-19-2019	EPINEPHrine 1:1000 INJECTION SOLUTION (PF) Syringe, 1 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0947-01	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1679-2019	06-19-2019	METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0902-10	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1713-2019	06-19-2019	TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0192-81	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1716-2019	06-19-2019	VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0976-30	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1718-2019	06-19-2019	ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0963-10	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1659-2019	06-19-2019	FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0207-89	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1704-2019	06-19-2019	SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0957-50	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1719-2019	06-19-2019	ZINC SULFATE 1MG/ML INJECTION SOLUTION, 30ML per VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0152-30	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated
D-1652-2019	06-19-2019	EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0922-30	Lack of Assurance of Sterility	RXQ Compounding LLC / N/A	Class II	Terminated