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-0444-2019 | 12-17-2018 | Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 158 10 ml vials | Class II | Terminated |
| D-0474-2019 | 12-17-2018 | Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 11 10ml vials | Class II | Terminated |
| D-0445-2019 | 12-17-2018 | Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 288 10 ml vials | Class II | Terminated |
| D-0454-2019 | 12-17-2018 | Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 139 vials | Class II | Terminated |
| D-0475-2019 | 12-17-2018 | Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 8 10ml vials | Class II | Terminated |
| D-0481-2019 | 12-17-2018 | Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 1 10 ml vial | Class II | Terminated |
| D-0447-2019 | 12-17-2018 | Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 94 vials | Class II | Terminated |
| D-0431-2019 | 12-17-2018 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684. | Lack of sterility assurance. | Promise Pharmacy, LLC / 75 10 ml bottles | Class II | Terminated |
| D-0455-2019 | 12-17-2018 | Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 93 vials | Class II | Terminated |
| D-0435-2019 | 12-17-2018 | Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2057 6 ml bottles | Class II | Terminated |
| D-0420-2019 | 12-17-2018 | Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 1306 capsules | Class II | Terminated |
| D-0438-2019 | 12-17-2018 | Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 204 10 ml vials | Class II | Terminated |
| D-0477-2019 | 12-17-2018 | Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 11 10 ml vials | Class II | Terminated |
| D-0439-2019 | 12-17-2018 | Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 3 30 ml vials | Class II | Terminated |
| D-0457-2019 | 12-17-2018 | Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 30 vials | Class II | Terminated |
| D-0453-2019 | 12-17-2018 | Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 416 vials | Class II | Terminated |
| D-0471-2019 | 12-17-2018 | Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2 10 ml vials | Class II | Terminated |
| D-0437-2019 | 12-17-2018 | Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 167 3 ml bottles | Class II | Terminated |
| D-0463-2019 | 12-17-2018 | Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 266 vials | Class II | Terminated |
| D-0432-2019 | 12-17-2018 | Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 43 3 mL bottles | Class II | Terminated |
| D-0470-2019 | 12-17-2018 | Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 5 vials | Class II | Terminated |
| D-0433-2019 | 12-17-2018 | Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 55 3 ml bottles | Class II | Terminated |
| D-0418-2019 | 12-17-2018 | Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 300 grams | Class II | Terminated |
| D-0480-2019 | 12-17-2018 | Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 3 | Class II | Terminated |
| D-0466-2019 | 12-17-2018 | ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 846 vials | Class II | Terminated |
| D-0464-2019 | 12-17-2018 | IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 59 vials | Class II | Terminated |
| D-0451-2019 | 12-17-2018 | Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 296 vials | Class II | Terminated |
| D-0479-2019 | 12-17-2018 | Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2 10ml vials | Class II | Terminated |
| D-0382-2019 | 12-14-2018 | Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02 | Failed Dissolution Specifications. | Cipla Limited / 4800 bottles | Class II | Terminated |
| D-0360-2019 | 12-14-2018 | Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4 | Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver | Results RNA, LLC / 10,297 bottles | Class I | Terminated |
| D-0354-2019 | 12-11-2018 | Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01 | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex | Asclemed USA Inc. dba Enovachem / | Class I | Terminated |
| D-0353-2019 | 12-11-2018 | Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01 | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex | Asclemed USA Inc. dba Enovachem / | Class I | Terminated |
| D-0340-2019 | 12-11-2018 | Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50 Package NDCs: 10702-201-01; 10702-201-50; 10702-201-10 | Labeling: Wrong bar code | KVK-Tech, Inc. / 156 bottles | Class II | Terminated |
| D-0294-2019 | 12-10-2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 Package NDCs: 55111-671-30; 55111-671-90; 55111-671-01; 55111-671-05; 55111-671-48; 55111-671-79; 55111-671-81; 55111-671-06; 55111-671-31; 55111-671-78 | Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing. | Dr. Reddy's Laboratories, Inc. / 4,404 (30 count blister packs) | Class II | Terminated |
| D-0341-2019 | 12-10-2018 | Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube. | Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. | CBI Laboratories, Inc. / 5363 tubes | Class III | Terminated |
| D-0338-2019 | 12-10-2018 | Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8. | Superpotent Drug: contains higher levels of Iron than labeled. | Gordon Laboratories / 1,155 boxes | Class II | Terminated |
| D-0342-2019 | 12-10-2018 | Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155 | Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. | CBI Laboratories, Inc. / 2055 tubes | Class III | Terminated |
| D-0425-2019 | 12-07-2018 | Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22 | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | US Pharmaceuticals Inc. / 19752 units | Class II | Terminated |
| D-0427-2019 | 12-07-2018 | Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060. | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | US Pharmaceuticals Inc. / 7020 units | Class II | Terminated |
| D-0426-2019 | 12-07-2018 | Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03 Package NDCs: 0363-0237-02; 0363-0237-03 | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | US Pharmaceuticals Inc. / 67848 units | Class II | Terminated |
| D-1207-2019 | 12-07-2018 | Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack) Package NDCs: 10631-115-69; 10631-115-31; 10631-116-69; 10631-116-31; 10631-117-69; 10631-117-31; 10631-118-69; 10631-118-31; 10631-133-69; 10631-133-31; 10631-134-69; 10631-134-31; 10631-002-31; 10631-003-31; 10631-004-31; 10631-005-31; 10631-006-31; 10631-007-31; 3106311173 | Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. | Sun Pharmaceutical Industries, Inc. / 47,520 prescription packs | Class III | Terminated |
| D-0339-2019 | 12-06-2018 | Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Superpotent Drug. | Pfizer Inc. / 1996 bottles | Class II | Terminated |
| D-0334-2019 | 12-05-2018 | Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48 | Sub-potent | Pharmedium Services, LLC / 295 100 mL in 150 mL Intravia bags | Class II | Terminated |
| D-0333-2019 | 12-05-2018 | Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75. | Sub-potent | Pharmedium Services, LLC / 295 50 ml in 60 ml syringes | Class II | Terminated |
| D-0332-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 32,284 HDPE bottles | Class II | Ongoing |
| D-0328-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 32,696 HDPE bottles | Class II | Ongoing |
| D-0322-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 109,314 HDPE bottles | Class II | Ongoing |
| D-0321-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 76,516 HDPE bottles | Class II | Ongoing |
| D-0330-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 22,813 HDPE bottles | Class II | Ongoing |
| D-0323-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 84,066 HDPE bottles | Class II | Ongoing |
| D-0320-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 141,995 HDPE bottles | Class II | Ongoing |
| D-0331-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 19,352 HDPE bottles | Class II | Ongoing |
| D-0329-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 50,595 HDPE bottles | Class II | Ongoing |
| D-0297-2019 | 12-04-2018 | Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01 Package NDCs: 42806-087-01; 42806-087-05; 42806-088-01; 42806-088-05; 42806-089-09; 42806-089-01; 42806-089-05 | Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets. | Epic Pharma, LLC / 2976 bottles | Class II | Terminated |
| D-0326-2019 | 12-04-2018 | Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 232,180 HDPE bottles | Class II | Ongoing |
| D-0327-2019 | 12-04-2018 | Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 129,754 HDPE bottles | Class II | Ongoing |
| D-0325-2019 | 12-04-2018 | Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 119,761 HDPE bottles | Class II | Ongoing |
| D-0324-2019 | 12-04-2018 | Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 160,300 HDPE bottles | Class II | Ongoing |
| D-0348-2019 | 11-30-2018 | NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 | Failed Impurities/Degradation Specifications:Out of specification for impurities. | VistaPharm, Inc. / 4,065,550 5 ml cups | Class III | Terminated |
| D-0289-2019 | 11-30-2018 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30 Package NDCs: 65862-854-30; 65862-855-30; 65862-856-30; 65862-857-30 | Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach). | Aurobindo Pharma USA Inc. / 4464 bottles | Class III | Terminated |
| D-0347-2019 | 11-29-2018 | Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61. | Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL". | Advanced Pharma Inc. / 225 syringes | Class I | Terminated |
| D-0349-2019 | 11-27-2018 | Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40 Package NDCs: 68462-583-11; 68462-583-85; 68462-583-40; 68462-584-58; 68462-584-40; 68462-584-76; 68462-585-40; 68462-585-76; 68462-112-33; 3684625834 | Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack. | Glenmark Pharmaceuticals Inc., USA / 5,016 blister packs | Class III | Terminated |
| D-0306-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 142,260 bottles | Class II | Ongoing |
| D-0307-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 41,572 bottles | Class II | Ongoing |
| D-0310-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 31,079 bottles | Class II | Ongoing |
| D-0308-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 19,458 bottles | Class II | Ongoing |
| D-0305-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 75,883 bottles | Class II | Ongoing |
| D-0309-2019 | 11-27-2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 37,957 bottles | Class II | Ongoing |
| D-0304-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 39,617 bottles | Class II | Ongoing |
| D-0303-2019 | 11-27-2018 | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Teva Pharmaceuticals USA / 120,394 bottles | Class II | Ongoing |
| D-0336-2019 | 11-26-2018 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen. | Tris Pharma Inc. / 19,488 bottles | Class II | Terminated |
| D-0335-2019 | 11-26-2018 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen. | Tris Pharma Inc. / 164,304 bottles | Class II | Terminated |
| D-0337-2019 | 11-26-2018 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen. | Tris Pharma Inc. / 20,736 bottles | Class II | Terminated |
| D-0295-2019 | 11-21-2018 | Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05 | Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | QuVa Pharma, Inc. / 168 bags | Class III | Terminated |
| D-0285-2019 | 11-20-2018 | Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408 | Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product | AVKARE Inc. / 1602 bags | Class II | Terminated |
| D-0317-2019 | 11-20-2018 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 5,660 bottles | Class II | Ongoing |
| D-0311-2019 | 11-20-2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 23,478 bottles | Class II | Ongoing |
| D-0318-2019 | 11-20-2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 48,302 bottles | Class II | Ongoing |
| D-0312-2019 | 11-20-2018 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 12,336 bottles | Class II | Ongoing |
| D-0314-2019 | 11-20-2018 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 12,840 bottles | Class II | Ongoing |
| D-0316-2019 | 11-20-2018 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 25,147 bottles | Class II | Ongoing |
| D-0315-2019 | 11-20-2018 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 63,213 bottles | Class II | Ongoing |
| D-0313-2019 | 11-20-2018 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77. Package NDCs: 0378-5807-93; 0378-5813-77; 0378-5814-77; 0378-5815-77 | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Mylan Pharmaceuticals Inc. / 24,709 bottles | Class II | Ongoing |
| D-0343-2019 | 11-19-2018 | Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Pharm D Solutions, LLC / 85 vials | Class II | Terminated |
| D-0293-2019 | 11-16-2018 | FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 602 cartons | Class II | Terminated |
| D-0292-2019 | 11-16-2018 | BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 803 units (400 kit and 403 30 ml bottles) | Class II | Terminated |
| D-0291-2019 | 11-16-2018 | SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 71 cartons | Class II | Terminated |
| D-0290-2019 | 11-16-2018 | fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105 | cGMP violations noted during the firm's most recent inspection. | CAO Group, Inc. / 115 kits | Class II | Terminated |
| D-0299-2019 | 11-15-2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620 Package NDCs: 63323-186-04; 63323-186-02; 63323-186-01; 63323-186-10; 63323-186-03; 63323-186-20 | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex. | Fresenius Kabi USA, LLC / 1,312,350 20 mL vials | Class I | Terminated |
| D-0298-2019 | 11-15-2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610 Package NDCs: 63323-186-04; 63323-186-02; 63323-186-01; 63323-186-10; 63323-186-03; 63323-186-20 | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex. | Fresenius Kabi USA, LLC / 23,745,300 10 mL vials | Class I | Terminated |
| D-0287-2019 | 11-14-2018 | Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1 Package NDCs: 67877-242-01; 67877-242-10; 67877-242-38; 67877-242-33; 67877-249-01; 67877-249-10; 67877-249-38; 67877-249-33; 67877-250-01; 67877-250-38; 67877-250-33; 67877-250-10; 67877-245-01; 67877-245-38; 67877-245-33; 67877-246-01; 67877-246-38; 67877-246-33; 67877-246-10; 67877-247-60; 67877-247-38; 67877-247-33; 67877-247-10; 67877-248-01; 67877-248-38; 67877-248-33; 67877-248-10 | Presence of Foreign Substance; metal shard found in tablet | Ascend Laboratories LLC / N/A | Class II | Terminated |
| D-0274-2019 | 11-09-2018 | Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41 Package NDCs: 47593-521-59; 47593-521-41; 47593-521-56; 47593-521-38; 47593-521-57; 47593-521-70 | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. | Ecolab Inc / 12,540 bottles | Class II | Terminated |
| D-0273-2019 | 11-09-2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11) | Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation." | AMERICAN HEALTH PACKAGING / 4508 blister packs | Class III | Terminated |
| D-0275-2019 | 11-09-2018 | Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59 | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. | Ecolab Inc / 14,108 bottles | Class II | Terminated |
| D-0282-2019 | 11-08-2018 | INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07 | Failed Stability Specification: out of specification for iron content. | ALLERGAN / 111,132 cartons/10 vials per carton | Class II | Terminated |
| D-0248-2019 | 11-08-2018 | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23 Package NDCs: 66733-948-23; 66733-958-23 | Labeling: Missing label; potential for missing primary container label on the vial. | Eli Lilly & Co / 9,380 vials | Class III | Terminated |
| D-0284-2019 | 11-07-2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard trays & HDPE 60 cc bottles in plastic bags, Repackaged NDC 70518-1087-01, 10 capsules in HDPE 60 cc bottles in cardboard trays. | Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine). | RemedyRepack Inc. / 3,148 capsules | Class III | Terminated |
| D-0283-2019 | 11-07-2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 Package NDCs: 55111-671-30; 55111-671-90; 55111-671-01; 55111-671-05; 55111-671-48; 55111-671-79; 55111-671-81; 55111-671-06; 55111-671-31; 55111-671-78 | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing. | Dr. Reddy's Laboratories, Inc. / 4,212 (30-count blister pack) | Class II | Terminated |
| D-0266-2019 | 11-06-2018 | Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post Street, San Francisco, CA 94104], [DG health brand NDC: 55910-717-72, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072] | Presence of foreign substance: Product found to contain metal particles. | L. Perrigo Company / 70,170 bottles | Class II | Terminated |
| D-0279-2019 | 11-06-2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031 | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing. | Breckenridge Pharmaceutical, Inc. / 9,193 bottles | Class III | Terminated |
