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-1100-2018 | 08-10-2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 9 bottles of 90 = 810 tablets | Class II | Terminated |
| D-1101-2018 | 08-10-2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 21 bottles of 90 = 1890 tablets | Class II | Terminated |
| D-1102-2018 | 08-10-2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | RemedyRepack Inc. / 36 bottles of 90 = 3240 tablets | Class II | Terminated |
| D-0090-2019 | 08-10-2018 | ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05 | Lack of Process Controls | Westlab Pharmacy, Inc. dba Westlab Pharmacy / 222 syringes | Class II | Terminated |
| D-1099-2018 | 08-09-2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99. Package NDCs: 51267-890-99; 51267-890-07 | Defective Container: Customer complaints of punctures in the bottle. | Orexigen Therapeutics, Inc. / 95,296 bottles | Class III | Terminated |
| D-1115-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227479 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 441,408 bottles | Class II | Completed |
| D-1113-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227453 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 316,380 bottles | Class II | Completed |
| D-1114-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227469 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 394,896 bottles | Class II | Completed |
| D-1116-2018 | 08-08-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902 Package NDCs: 31722-745-30; 31722-745-90; 31722-745-05; 31722-745-31; 31722-745-32; 31722-746-30; 31722-746-90; 31722-746-05; 31722-746-31; 31722-746-32; 31722-747-30; 31722-747-90; 31722-747-05; 31722-747-31; 31722-747-32; 31722-748-30; 31722-748-90; 31722-748-05; 31722-748-31; 31722-748-32; 3317227489 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Hetero Labs Limited Unit V / 441,408 bottles | Class II | Completed |
| D-1168-2018 | 08-08-2018 | Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10 | Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide | Akorn, Inc. / 8,574 bottles | Class III | Terminated |
| D-1186-2018 | 08-07-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01 | Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. | Mylan Pharmaceuticals Inc. / 11,799 bottles of 100 | Class III | Terminated |
| D-1127-2018 | 08-07-2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127. Package NDCs: 55289-866-02; 55289-866-04; 55289-866-06; 55289-866-07; 55289-866-10; 55289-866-20; 55289-866-28; 55289-866-30; 55289-866-50; 55289-866-60; 55289-866-71; 55289-866-74; 55289-866-85; 55289-866-86; 55289-866-87; 55289-866-90; 55289-866-93; 55289-866-98; 55289-866-01; 55289-866-82; 55289-866-95; 55289-866-14 | Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results. | PD-Rx Pharmaceuticals, Inc. / 6,641 bottles | Class II | Terminated |
| D-1187-2018 | 08-07-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05 | Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. | Mylan Pharmaceuticals Inc. / 656 500-count bottles | Class III | Terminated |
| D-0099-2019 | 08-06-2018 | Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 3,397 bottles | Class II | Terminated |
| D-0096-2019 | 08-06-2018 | Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 27,816 bottles | Class II | Terminated |
| D-0100-2019 | 08-06-2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 82,291 bottles | Class II | Terminated |
| D-0101-2019 | 08-06-2018 | Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0102-2019 | 08-06-2018 | PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / N/A | Class II | Terminated |
| D-0097-2019 | 08-06-2018 | Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 3,785 bottles | Class II | Terminated |
| D-0098-2019 | 08-06-2018 | Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60 | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. | Teva Pharmaceuticals USA / 13,225 bottles | Class II | Terminated |
| D-0047-2019 | 08-03-2018 | Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4992 bottles | Class II | Terminated |
| D-0077-2019 | 08-03-2018 | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0071-2019 | 08-03-2018 | CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7. | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus. | Product Quest Manufacturing LLC / 25,596 sticks | Class II | Terminated |
| D-0033-2019 | 08-03-2018 | CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 42,792 bottles | Class II | Terminated |
| D-0039-2019 | 08-03-2018 | Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 5040 tubes | Class II | Terminated |
| D-0062-2019 | 08-03-2018 | Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 361,104 bottles | Class II | Terminated |
| D-0064-2019 | 08-03-2018 | Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 533,016 bottles | Class II | Terminated |
| D-0073-2019 | 08-03-2018 | CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0. | Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. | Product Quest Manufacturing LLC / 11,016 cans | Class II | Terminated |
| D-0028-2019 | 08-03-2018 | Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4040 bottles | Class II | Terminated |
| D-0055-2019 | 08-03-2018 | OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 3,442,536 bottles | Class II | Terminated |
| D-0054-2019 | 08-03-2018 | TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 7,488 tubes | Class II | Terminated |
| D-0038-2019 | 08-03-2018 | FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 46,056 cans | Class II | Terminated |
| D-0029-2019 | 08-03-2018 | CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4464 tubes | Class II | Terminated |
| D-0041-2019 | 08-03-2018 | meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 182,568 bottles | Class II | Terminated |
| D-0046-2019 | 08-03-2018 | Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 10,584 cans | Class II | Terminated |
| D-0057-2019 | 08-03-2018 | Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 1008 bottles | Class II | Terminated |
| D-0061-2019 | 08-03-2018 | Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 286,176 bottles | Class II | Terminated |
| D-0045-2019 | 08-03-2018 | Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01519 9. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 9024 bottles | Class II | Terminated |
| D-0030-2019 | 08-03-2018 | CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 529,536 cans | Class II | Terminated |
| D-0044-2019 | 08-03-2018 | Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 8592 bottles | Class II | Terminated |
| D-0036-2019 | 08-03-2018 | Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256 | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 21,492 bottles | Class II | Terminated |
| D-0076-2019 | 08-03-2018 | Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201 | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0037-2019 | 08-03-2018 | DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 786,720 bottles | Class II | Terminated |
| D-0035-2019 | 08-03-2018 | CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 552 bottles | Class II | Terminated |
| D-0050-2019 | 08-03-2018 | QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 172,800 bottles | Class II | Terminated |
| D-0069-2019 | 08-03-2018 | Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0. | Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. | Product Quest Manufacturing LLC / 6,516 tubes | Class III | Terminated |
| D-0048-2019 | 08-03-2018 | Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 102,348 bottles | Class II | Terminated |
| D-0065-2019 | 08-03-2018 | dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7. | Failed Stability Specifications: separation of product and failure for actives. | Product Quest Manufacturing LLC / 9,480 tubes | Class II | Terminated |
| D-0051-2019 | 08-03-2018 | Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 114,336 bottles | Class II | Terminated |
| D-0075-2019 | 08-03-2018 | Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0034-2019 | 08-03-2018 | CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 285,840 tubes | Class II | Terminated |
| D-0053-2019 | 08-03-2018 | Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 22,392 bottles | Class II | Terminated |
| D-0049-2019 | 08-03-2018 | QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 4,200 tubes | Class II | Terminated |
| D-0056-2019 | 08-03-2018 | Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 2,112 bottles | Class II | Terminated |
| D-0078-2019 | 08-03-2018 | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901) | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-0068-2019 | 08-03-2018 | Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341 | Superpotent Drug: high out of specification assay results for the menthol ingredient. | Product Quest Manufacturing LLC / 4,692 tubes | Class II | Terminated |
| D-0079-2019 | 08-03-2018 | Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-1076-2018 | 08-03-2018 | Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02 | Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label. | Huijing (Shanghai) Bio-tech Co., Ltd. / 75,000 pads | Class III | Terminated |
| D-0043-2019 | 08-03-2018 | HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 . | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 3264 bottles | Class II | Terminated |
| D-0063-2019 | 08-03-2018 | Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 355,056 bottles | Class II | Terminated |
| D-0052-2019 | 08-03-2018 | Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 16,944 cans | Class II | Terminated |
| D-0070-2019 | 08-03-2018 | Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7. | Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. | Product Quest Manufacturing LLC / 7,944 tubes | Class III | Terminated |
| D-0072-2019 | 08-03-2018 | Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3. | Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid. | Product Quest Manufacturing LLC / 1,440 tubes | Class II | Terminated |
| D-0080-2019 | 08-03-2018 | Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / Unknown | Class II | Terminated |
| D-1179-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1181-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1180-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-155-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1182-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-1178-2018 | 08-03-2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04. | Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled. | Westminster Pharmaceuticals LLC / Unknown | Class I | Terminated |
| D-0074-2019 | 08-03-2018 | Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5. | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa. | Product Quest Manufacturing LLC / 16 bottles | Class I | Terminated |
| D-0031-2019 | 08-03-2018 | CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 552 bottles | Class II | Terminated |
| D-0032-2019 | 08-03-2018 | CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 277,587 cans | Class II | Terminated |
| D-0067-2019 | 08-03-2018 | Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1. | Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. | Product Quest Manufacturing LLC / 5,004 tubes | Class II | Terminated |
| D-0027-2019 | 08-03-2018 | DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3. | Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. | Product Quest Manufacturing LLC / 5025 sticks | Class II | Terminated |
| D-0059-2019 | 08-03-2018 | Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 30,096 bottles | Class II | Terminated |
| D-0042-2019 | 08-03-2018 | Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 37,464 cans | Class II | Terminated |
| D-0066-2019 | 08-03-2018 | FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6. | Superpotent Drug: high out of specification assay results for the camphor ingredient. | Product Quest Manufacturing LLC / 6,109 cans | Class II | Terminated |
| D-0058-2019 | 08-03-2018 | Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 59895 4. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 3,600 bottles | Class II | Terminated |
| D-0060-2019 | 08-03-2018 | Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 141,888 bottles | Class II | Terminated |
| D-0040-2019 | 08-03-2018 | Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC / 39,924 bottles | Class II | Terminated |
| D-1079-2018 | 08-02-2018 | Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets. | Dr. Reddy's Laboratories, Inc. / 2280 bottles | Class III | Terminated |
| D-1148-2018 | 08-02-2018 | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 864 vials | Class II | Terminated |
| D-1152-2018 | 08-02-2018 | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 3351 vials | Class II | Terminated |
| D-1155-2018 | 08-02-2018 | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 599 vials | Class II | Terminated |
| D-1153-2018 | 08-02-2018 | Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 6 vials | Class II | Terminated |
| D-1154-2018 | 08-02-2018 | Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 1115 vials | Class II | Terminated |
| D-1150-2018 | 08-02-2018 | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 3070 vials | Class II | Terminated |
| D-1149-2018 | 08-02-2018 | Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 355 vials | Class II | Terminated |
| D-1151-2018 | 08-02-2018 | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 2085 vials | Class II | Terminated |
| D-1147-2018 | 08-02-2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Lack of assurance of sterility. | Pharmcore Inc. / 5718 vials | Class II | Terminated |
| D-1582-2019 | 08-01-2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11 Package NDCs: 62584-693-11; 62584-693-21 | Failed Dissolution Specifications: Out of specification result for the dissolution test. | American Health Packaging / 6,579 cartons | Class II | Terminated |
| D-1035-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 106,320 bags | Class III | Terminated |
| D-1036-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 711,216 bags | Class III | Terminated |
| D-1046-2018 | 08-01-2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30 | Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months. | Akorn, Inc. / 22,605 tubes | Class II | Terminated |
| D-1034-2018 | 08-01-2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 191,256 bags | Class III | Terminated |
| D-1026-2018 | 07-30-2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04 Package NDCs: 0904-0430-95; 0904-0430-04; 0904-0430-06 | Failed Dissolution Specifications | MAJOR PHARMACEUTICALS / 3,161 Cartons | Class II | Terminated |
| D-1038-2018 | 07-30-2018 | Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1039-2018 | 07-30-2018 | Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1037-2018 | 07-30-2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | NuCare Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-1028-2018 | 07-27-2018 | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Bryant Ranch Prepack Inc. / 990 tablets | Class II | Terminated |
