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 July 04, 2025 and include a total of 16930 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-1352-201507-30-2015Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
Package NDCs: 29300-128-01; 29300-128-05; 29300-128-10; 29300-128-50; 29300-129-01; 29300-129-05; 29300-129-10; 29300-129-50; 29300-485-01; 29300-485-10
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.Unichem Pharmaceuticals Usa Inc / 4776 bottlesClass IITerminated
D-1406-201507-29-2015Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811Failed Dissolution SpecificationsVintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals / 8,705 bottlesClass IITerminated
D-1347-201507-29-2015Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.Wockhardt Usa Inc. / 3378 bottlesClass IITerminated
D-1346-201507-29-2015Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.Wockhardt Usa Inc. / 1704 bottlesClass IITerminated
D-1430-201507-28-2015Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.Novartis Pharmaceuticals Corp. / 10,767 bottlesClass IIITerminated
D-0033-201607-28-2015Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 11,232 boxesClass IIITerminated
D-1327-201507-28-2015Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Package NDCs: 63323-614-00; 63323-614-01
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)Fresenius Kabi USA, LLC / 93,000 vialsClass IIITerminated
D-0037-201607-28-2015Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / N/AClass IIITerminated
D-0031-201607-28-2015Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 29,360 boxesClass IIITerminated
D-0023-201607-28-2015CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 291,312 boxesClass IIITerminated
D-0025-201607-28-2015Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USASuperpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 43,344 boxesClass IIITerminated
D-0035-201607-28-2015TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 53,688 boxesClass IIITerminated
D-0029-201607-28-2015HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 25,488 boxesClass IIITerminated
D-0019-201607-28-2015QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 8,735 unitsClass IIITerminated
D-0020-201607-28-2015Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 90,410 unitsClass IIITerminated
D-0030-201607-28-2015Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 9,624 boxesClass IIITerminated
D-0024-201607-28-2015Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 4,176 unitsClass IIITerminated
D-0022-201607-28-2015CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 21,356 boxesClass IIITerminated
D-0038-201607-28-2015Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 329,748 boxesClass IIITerminated
D-0021-201607-28-2015Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 18576 boxesClass IIITerminated
D-0028-201607-28-2015Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 35,712 boxesClass IIITerminated
D-0034-201607-28-2015Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 33,984 boxesClass IIITerminated
D-0027-201607-28-2015Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / N/AClass IIITerminated
D-0039-201607-28-2015Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 5,040 boxesClass IIITerminated
D-0032-201607-28-2015Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
Package NDCs: 51660-527-31; 5166052731
Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 311 boxesClass IIITerminated
D-0026-201607-28-2015Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 12,960 boxesClass IIITerminated
D-0036-201607-28-2015Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5Superpotent Drug: Out Of Specification (OOS) result for Assay.Ohm Laboratories, Inc. / 34,488 boxesClass IIITerminated
D-0008-201607-27-2015Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.Noven Pharmaceuticals, Inc. / 125,250 PatchesClass IITerminated
D-0112-201607-24-2015PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/0. 1MG/10MCG/ML, syringe 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringeClass IITerminated
D-0086-201607-24-2015ESTRADIOL, Pellet, 6 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 79 pelletsClass IITerminated
D-0096-201607-24-2015HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25 mL, syringe sizes: 20 mL and 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 3 (30mL) syringes, 1 (20mL) syringeClass IITerminated
D-0094-201607-24-2015GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringesClass IITerminated
D-0116-201607-24-2015PROGESTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 21 pelletsClass IITerminated
D-0064-201607-24-2015CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 9 (4mL), 4 (5mL) vials, 9 (6mL) vials, 5 (7.5mL) vials, 4 (10mL) vials, 5 (9mL) vials, 3 (12mL) vials, 2 (15mL) vials, 1 (20mL), 1 (28mL) vialsClass IITerminated
D-0118-201607-24-2015PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 5 pelletsClass IITerminated
D-0079-201607-24-2015ESTRADIOL, Pellet, 12 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pelletClass IITerminated
D-0121-201607-24-2015SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 165 syringesClass IITerminated
D-0148-201607-24-2015TRIMIX, injectable Solution, 20MG/1MG/20MCG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 155 syringesClass IITerminated
D-0105-201607-24-2015METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (4mL) syringe, 5 (10mL) syringes, 1 (12mL) syringe, 4 (15mL) syringes, 13 (30mL) syringes, 2 (50mL) syringes, 3 (60mL) syringesClass IITerminated
D-0153-201607-24-2015VITAMIN B-COMPLEX, Injectable Solution, Syringe size: 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 3 syringesClass IITerminated
D-0072-201607-24-2015CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 26 syringesClass IITerminated
D-0144-201607-24-2015TESTOSTERONE PROPRIONATE, Injectable Solution, 100 mg/mL, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 5 syringesClass IITerminated
D-0075-201607-24-2015DIHYDROERGOTAMINE MESYLATE, Injectable Solution, 1 MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 8 syringesClass IITerminated
D-0117-201607-24-2015PROGESTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 5 pelletsClass IITerminated
D-0123-201607-24-2015SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD & SN Inc, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 100 syringesClass IITerminated
D-0081-201607-24-2015ESTRADIOL, Pellet, 20 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 9 pelletsClass IITerminated
D-0106-201607-24-2015METHYLCOBALAMIN MDV, Injectable Solution, 2 MG/ML, 10mL syringe; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringeClass IITerminated
D-0142-201607-24-2015TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 100 mg/mL, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringeClass IITerminated
D-0065-201607-24-2015CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 9 (5mL) vials, 2 (6mL) vials, 8 (8mL) vials, 2 (10mL) vialsClass IITerminated
D-0058-201607-24-2015B1/B2/B3/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/50/5/1/10/25/8/17/17 MG/ML, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 5 vialsClass IITerminated
D-0114-201607-24-2015PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/10 MCG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringesClass IITerminated
D-0063-201607-24-2015CHORIONIC GONADOTROPIN, Injectable Solution,175 UNITS/1.5mg per syringe with Methylcobalamin, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 834 syringesClass IITerminated
D-0092-201607-24-2015GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (60mL) syringe, 3 (90mL) syringe, 5 (100mL) syringe, 1 (150mL) syringeClass IITerminated
D-0125-201607-24-2015TESTOSTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 92 pelletsClass IITerminated
D-0149-201607-24-2015TRIMIX, injectable Solution, 30MG/1MG/10MCG, syringe sizes: 5 mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 8 (10mL) syringes, 1 (5mL) syringeClass IITerminated
D-0113-201607-24-2015PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 30 MG/2 MG/0. 1MG/20MCG, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringeClass IITerminated
D-0155-201607-24-2015VITAMIN D3 OIL, Injectable Solution, 50,000 UNITS/ML, syringe sizes: 10 mL and 30 mL, Rx only,JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 6 (30mL syringe), 2 (10mL syringe)Class IITerminated
D-0087-201607-24-2015ESTRADIOL, Pellet, 75 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 6 pelletsClass IITerminated
D-0101-201607-24-2015MEDROXYPROGESTERONE ACETATE, injectable Solution,150MG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 11 SyringesClass IITerminated
D-0070-201607-24-2015CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 64 syringesClass IITerminated
D-0077-201607-24-2015EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringeClass IITerminated
D-0098-201607-24-2015HYDROXOCOBALAMIN MULTIDOSE VIAL, Injectable Solution, 5 mg/mL, syringe sizes: 6 mL, 10 mL, 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 (6mL) syringes, 5 (10mL) syringes, 1 (30mL) syringeClass IITerminated
D-1351-201507-24-2015ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solutionTeva Pharmaceuticals USA / 6001 vialsClass ITerminated
D-0143-201607-24-2015TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size: 5ml and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 243 (10mL) syringes, 5 (5mL) syringesClass IITerminated
D-0151-201607-24-2015TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 10 syringesClass IITerminated
D-0073-201607-24-2015CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 30 syringesClass IITerminated
D-0082-201607-24-2015ESTRADIOL, Injectable Solution, 20 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringesClass IITerminated
D-0133-201607-24-2015TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pelletClass IITerminated
D-0131-201607-24-2015TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 20 pelletsClass IITerminated
D-0128-201607-24-2015TESTOSTERONE, Pellet, 112 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 91 pelletsClass IITerminated
D-0097-201607-24-2015HYDROXOCOBALAMIN (COMPOUNDED), Injectable Solution, 1 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 3 syringesClass IITerminated
D-0115-201607-24-2015PROCAINE MDV, Injectable Solution,1%, container sizes: 30mL and 300mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (300mL) container, 1 (30mL) containerClass IITerminated
D-0150-201607-24-2015TRIMIX, injectable Solution, 30MG/1MG/20MCG, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 6 syringesClass IITerminated
D-0084-201607-24-2015ESTRADIOL, Pellet, 30 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pelletClass IITerminated
D-0088-201607-24-2015ESTRADIOL, Pellet, 9 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 6 pelletsClass IITerminated
D-0067-201607-24-2015CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 175 UNITS/0.175ML per syringe, packaged in 14, 26, and 40-count containers, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (14-count) container, 1(40-count) container, 30 (26-count) containerClass IITerminated
D-0147-201607-24-2015TRIMIX, injectable Solution, 15MG/.5MG/5MCG/ML, 10mL syringe, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 15 syringesClass IITerminated
D-0068-201607-24-2015CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 200 UNITS/0.2ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 184 syringesClass IITerminated
D-0135-201607-24-2015TESTOSTERONE, Pellet, 50 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 16 pelletsClass IITerminated
D-0059-201607-24-2015B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/5/1/10/25/8/17/17 MG/ML, 30 mM vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 22 vialsClass IITerminated
D-0091-201607-24-2015FOLIC ACID, Injectable Solution, 10 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 6 syringesClass IITerminated
D-0154-201607-24-2015VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 4 syringesClass IITerminated
D-0102-201607-24-2015METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringesClass IITerminated
D-1279-201507-24-2015COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.
Package NDCs: 0597-0024-02
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.Boehringer Ingelheim Roxane Inc / 358,647 inhalersClass IITerminated
D-0104-201607-24-2015METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (5mL) syringe, 1 (6mL) syringe, 18 (10mL), 1 (15mL) syringe, 3 (20mL) syringe, 3 (30mL) syringeClass IITerminated
D-0145-201607-24-2015TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 20 pelletsClass IITerminated
D-0080-201607-24-2015ESTRADIOL, Pellet, 18 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pelletClass IITerminated
D-0060-201607-24-2015CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 4 vialsClass IITerminated
D-0109-201607-24-2015METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution,1 mg/mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 36 syringesClass IITerminated
D-0076-201607-24-2015DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY), Injectable Solution, 500 mg/mL, 5mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringeClass IITerminated
D-0137-201607-24-2015TESTOSTERONE, Pellet, 70 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 6 pelletsClass IITerminated
D-0057-201607-24-2015ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 27 vialsClass IITerminated
D-0146-201607-24-2015TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 60 pelletsClass IITerminated
D-0108-201607-24-2015METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution, 15 MG/ML, syringe size: 12 mL, 20 mL, 30 mL, 40 mL, 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (12mL) syringe, 204 (20mL) syringe, 3 (30mL) syringes, 3 (40mL) syringes, 1 (60mL) syringeClass IITerminated
D-0132-201607-24-2015TESTOSTERONE, Pellet, 125 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 355 pelletsClass IITerminated
D-0130-201607-24-2015TESTOSTERONE, Pellet, 116 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pelletClass IITerminated
D-0078-201607-24-2015ESTRADIOL, Pellet, 12.5 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 pelletsClass IITerminated
D-0140-201607-24-2015TESTOSTERONE, Pellet, 90 mg, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 36 pelletsClass IITerminated
D-0093-201607-24-2015GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL syringe , Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringesClass IITerminated
D-0085-201607-24-2015ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314Lack of Assurance of Sterility; all sterile human compounded drugs within expiryJD & SN Inc., dba Moses Lake Professional Pharmacy / 68 pelletsClass IITerminated