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-1513-2014 | 07-14-2014 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07. | Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. | Wockhardt Usa Inc. / 840 bottles | Class III | Terminated |
| D-1508-2014 | 07-12-2014 | Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. | Daiichi Sankyo Pharma Development / | Class II | Terminated |
| D-1502-2014 | 07-12-2014 | Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 262 bottles | Class II | Terminated |
| D-1507-2014 | 07-12-2014 | Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. | Daiichi Sankyo Pharma Development / 86 bottles | Class II | Terminated |
| D-1506-2014 | 07-12-2014 | Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. | Daiichi Sankyo Pharma Development / | Class II | Terminated |
| D-1503-2014 | 07-12-2014 | Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 108 bottles | Class II | Terminated |
| D-1501-2014 | 07-12-2014 | Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 5 bottles | Class II | Terminated |
| D-1505-2014 | 07-12-2014 | Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / 68 bottles | Class II | Terminated |
| D-1504-2014 | 07-12-2014 | Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30 | Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping | Daiichi Sankyo Pharma Development / | Class II | Terminated |
| D-1592-2014 | 07-11-2014 | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043. Package NDCs: 0338-0553-11; 0338-0553-18 | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Baxter Healthcare Corp. / 390,560 bags | Class I | Terminated |
| D-1591-2014 | 07-11-2014 | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Baxter Healthcare Corp. / a) 217,536 bags; b) 161,760 bags | Class I | Terminated |
| D-1593-2014 | 07-11-2014 | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822. Package NDCs: 0338-0703-41; 0338-0703-48; 0338-0705-41; 0338-0705-48; 0338-0709-48 | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Baxter Healthcare Corp. / 171,672 bags | Class I | Terminated |
| D-1500-2014 | 07-11-2014 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90 Package NDCs: 59746-337-30; 59746-337-90; 59746-337-01; 59746-337-10; 59746-338-30; 59746-338-90; 59746-338-01; 59746-338-10; 59746-339-30; 59746-339-90; 59746-339-01; 59746-339-10 | Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. | Jubilant Cadista Pharmaceuticals Inc. / 9,358 bottles | Class II | Terminated |
| D-1445-2014 | 07-11-2014 | Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540. Package NDCs: 0185-0022-10; 0185-0022-01 | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. | Sandoz Inc / 781,000 extended release tablets | Class III | Terminated |
| D-0392-2015 | 07-10-2014 | LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09 | Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold. | Hospira Inc. / 142,644 bags | Class I | Terminated |
| D-0021-2015 | 07-09-2014 | Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 10 Kg | Class II | Terminated |
| D-0022-2015 | 07-09-2014 | Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 1 Kg | Class II | Terminated |
| D-0024-2015 | 07-09-2014 | Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 97 Kg | Class II | Terminated |
| D-0023-2015 | 07-09-2014 | Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01 | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. | Gyma Laboratories Of Amer,Inc / 55.8 Kg | Class II | Terminated |
| D-1443-2014 | 07-08-2014 | VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70 Package NDCs: 63010-010-30; 63010-027-70 | Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016. | Pfizer Inc. / 1200 tablets | Class III | Terminated |
| D-0009-2015 | 07-03-2014 | Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77. | Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol | Mylan Pharmaceuticals Inc. / 15,966 bottles | Class II | Terminated |
| D-1441-2014 | 07-03-2014 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60. | Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. | Fougera Pharmaceuticals Inc. / 3,594 Bottles | Class III | Terminated |
| D-1435-2014 | 07-03-2014 | Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08. | Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,184 cartons | Class III | Terminated |
| D-1440-2014 | 07-03-2014 | Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60. | Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry. | Fougera Pharmaceuticals Inc. / 111,388 Bottles | Class III | Terminated |
| D-1536-2014 | 07-02-2014 | E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01. Package NDCs: 32909-764-01 | Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months. | Bracco Diagnostic Inc / 216,792 bottles | Class III | Terminated |
| D-1590-2014 | 07-01-2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01 | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544. | American Health Packaging / 59,200 tablets | Class I | Terminated |
| D-1589-2014 | 07-01-2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01 | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544 | American Health Packaging / 137,300 tablets | Class I | Terminated |
| D-1552-2014 | 06-27-2014 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 48 bags | Class II | Terminated |
| D-1554-2014 | 06-27-2014 | fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-33 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 220 syringes | Class II | Terminated |
| D-1551-2014 | 06-27-2014 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 50 syringes | Class II | Terminated |
| D-1553-2014 | 06-27-2014 | fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / 12 bags | Class II | Terminated |
| D-1555-2014 | 06-27-2014 | fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04 | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. | Healix Infusion Therapy, Inc. / | Class II | Terminated |
| D-1433-201 | 06-27-2014 | Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61. Package NDCs: 0409-9093-41; 0409-9093-36; 0409-9093-31; 0409-9093-38; 0409-9094-12; 0409-9094-22; 0409-9094-18; 0409-9094-25; 0409-9094-17; 0409-9094-28; 0409-9094-16; 0409-9094-31; 0409-9094-41; 0409-9094-61 | Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. | Hospira Inc. / 47,400 vials | Class II | Terminated |
| D-1431-2014 | 06-26-2014 | POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16. | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". | Poly Pharmaceuticals, Inc / 208 Bottles | Class III | Terminated |
| D-1510-2014 | 06-26-2014 | Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. | CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. | Caraco Pharmaceutical Laboratories, Ltd. / a) 70,152 bottles; b) 43,525 bottles | Class II | Terminated |
| D-1432-2014 | 06-26-2014 | LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16. | Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only". | Poly Pharmaceuticals, Inc / 102 Bottles | Class III | Terminated |
| D-1511-2014 | 06-26-2014 | Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. | CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. | Caraco Pharmaceutical Laboratories, Ltd. / a) 43,585 bottles; b) 296,968 bottles | Class II | Terminated |
| D-1533-2014 | 06-25-2014 | Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1522-2014 | 06-25-2014 | Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1520-1014 | 06-25-2014 | Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1519-2014 | 06-25-2014 | Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1532-2014 | 06-25-2014 | L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1521-2014 | 06-25-2014 | BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1524-2014 | 06-25-2014 | Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1530-2014 | 06-25-2014 | Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1529-2014 | 06-25-2014 | Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1526-2014 | 06-25-2014 | Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1528-2014 | 06-25-2014 | B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1523-2014 | 06-25-2014 | Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1525-2014 | 06-25-2014 | MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1531-2014 | 06-25-2014 | G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1546-2014 | 06-25-2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869. | Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination. | Pharmacy Creations / 70 vials | Class I | Terminated |
| D-1527-2014 | 06-25-2014 | Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. | Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer | Medical Supply Liquidators Llc / N/A | Class II | Terminated |
| D-1549-2014 | 06-24-2014 | Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673 | Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug. | Doctor's Best, Inc. / 7,379 bottles | Class II | Terminated |
| D-1539-2014 | 06-20-2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91. | Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. | Mylan Pharmaceuticals Inc. / 9225 Bottles | Class III | Terminated |
| D-1484-2014 | 06-20-2014 | Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11. Package NDCs: 43386-500-11 | Failed Impurity/Degradation Specification; 12-month stability time point | Novel Laboratories, Inc. / 25,776 containers | Class III | Terminated |
| D-1557-2014 | 06-19-2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. | Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. | Mylan Pharmaceuticals Inc. / 2,658 Bottles | Class III | Terminated |
| D-1412-2014 | 06-19-2014 | Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07. | Failed Dissolution Specifications: Drug failed stage III dissolution testing. | Forest Pharmaceuticals Inc / 92,544 Bottles | Class II | Terminated |
| D-1483-2014 | 06-19-2014 | Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC | Failed Dissolution Specification; at the 12 month time interval. | Mckesson Packaging Services / 1,511,250 tablets | Class III | Terminated |
| D-1485-2014 | 06-19-2014 | Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30 | Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. | Pfizer Inc. / 22,461 bottles | Class III | Terminated |
| D-0002-2015 | 06-17-2014 | Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29 Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. | Hospira Inc. / 40,730 vials | Class I | Terminated |
| D-1439-2014 | 06-17-2014 | Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 Package NDCs: 0555-9051-79; 0555-9051-67 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 5265 blister packs | Class III | Terminated |
| D-1436-2014 | 06-17-2014 | Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 Package NDCs: 0555-9043-79; 0555-9043-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 1104 blister packs | Class III | Terminated |
| D-1437-2014 | 06-17-2014 | Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 984 blister packs | Class III | Terminated |
| D-1438-2014 | 06-17-2014 | Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58 Package NDCs: 0555-9050-79; 0555-9050-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Teva Pharmaceuticals USA / 1125 blister packs | Class III | Terminated |
| D-1413-2014 | 06-16-2014 | Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61. Package NDCs: 10019-115-39; 10019-115-01; 10019-075-87; 10019-055-61 | Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. | Baxter Healthcare Corp. / 20,810 containers | Class II | Terminated |
| D-1383-2014 | 06-12-2014 | Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. | Thorne Research Inc / unknown | Class II | Terminated |
| D-1384-2014 | 06-12-2014 | Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1 | Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs. | Thorne Research Inc / unknown | Class II | Terminated |
| D-1415-2014 | 06-12-2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81. | Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications. | Caraco Pharmaceutical Laboratories, Ltd. / 26,530 30-Count Bottles; 14,597 90-Count Bottles | Class II | Terminated |
| D-1452-2014 | 06-06-2014 | DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France | Stability Data Does Not Support Expiry | Estee Lauder Inc / 3,791 tubes | Class III | Terminated |
| D-1425-2014 | 06-06-2014 | Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62 Package NDCs: 0409-7793-52; 0409-7793-62; 0409-7793-13; 0409-7793-23; 0409-7794-52; 0409-7794-62; 0409-4520-02; 0409-4520-30 | Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag. | Hospira Inc. / 142,152 bags | Class II | Terminated |
| D-1538-2014 | 06-05-2014 | Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10 | Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets. | Teva Pharmaceuticals USA / 3881bottles | Class II | Terminated |
| D-0053-2015 | 06-05-2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC / 55,650 HDPE bottles | Class III | Terminated |
| D-0051-2015 | 06-05-2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07. | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC / 20,499 HDPE bottles | Class III | Terminated |
| D-0052-2015 | 06-05-2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7 | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC / 23,057 HDPE bottles | Class III | Terminated |
| D-0017-2015 | 06-02-2014 | Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 | Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium | Unit Dose Solutions Inc / 1,177 packets | Class II | Terminated |
| D-1512-2014 | 06-02-2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Package NDCs: 25682-001-01 | Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. | Alexion Pharmaceuticals, Inc. / 96,506 vials | Class I | Terminated |
| D-1420-2014 | 05-30-2014 | HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 55 mL | Class II | Terminated |
| D-1418-2014 | 05-30-2014 | HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 184 mL | Class II | Terminated |
| D-1417-2014 | 05-30-2014 | Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 30 mL | Class II | Terminated |
| D-1419-2014 | 05-30-2014 | HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 850 tablets | Class II | Terminated |
| D-1416-2014 | 05-30-2014 | Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 6000 mL | Class II | Terminated |
| D-1421-2014 | 05-30-2014 | HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent. | Brookfield Prescription Center Inc. dba MD Custom Rx / 8 mL | Class II | Terminated |
| D-1430-2014 | 05-29-2014 | Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56 Package NDCs: 0093-7442-56; 0093-7442-01; 0093-7443-56; 0093-7443-01 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 8,472 Bottles | Class II | Terminated |
| D-1559-2014 | 05-28-2014 | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 1 dose | Class I | Terminated |
| D-1562-2014 | 05-28-2014 | LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 4 doses | Class I | Terminated |
| D-1387-2014 | 05-28-2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01 | Failed Stability Specification; out of specification result for particle size distribution during stability testing | Novartis Pharmaceuticals Corp. / Lot F0067: 45,834 units; Lot F0079: 63,321 units | Class III | Terminated |
| D-1560-2014 | 05-28-2014 | del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 31 doses | Class I | Terminated |
| D-1561-2014 | 05-28-2014 | adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. / 5 doses | Class I | Terminated |
| D-1381-2014 | 05-23-2014 | Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01 Package NDCs: 55111-466-30; 55111-466-60; 55111-466-01; 55111-466-05; 55111-466-79; 55111-466-78; 55111-467-30; 55111-467-60; 55111-467-01; 55111-467-05; 55111-467-79; 55111-467-78 | Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. | Dr. Reddy's Laboratories, Inc. / 13560 bottles | Class II | Terminated |
| D-1350-2014 | 05-22-2014 | Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. Package NDCs: 0781-5438-20; 0781-5438-01; 0781-5439-20; 0781-5439-01 | Presence of Foreign Substance: Presence of stainless steel particles. | Sandoz, Inc / 22,818 Bottles | Class II | Terminated |
| D-0042-2015 | 05-22-2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India | Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg | Aidarex Pharmaceuticals LLC / 531 bottles | Class II | Terminated |
| D-0018-2015 | 05-21-2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada Package NDCs: 0187-0146-01 | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset | Valeant Pharmaceuticals North America LLC / 205,853 bottles | Class III | Terminated |
| D-0019-2015 | 05-21-2014 | Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles Package NDCs: 0187-0140-30; 0187-0140-90; 0187-0141-30; 0187-0141-90; 0187-0141-10; 0187-0142-30; 0187-0142-90; 0187-0142-10; 0187-0143-30; 0187-0143-90; 0187-0143-10 | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. | Valeant Pharmaceuticals North America LLC / 205,853 bottles | Class III | Terminated |
| D-0447-2017 | 05-20-2014 | Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. | Cambrex Charles City Inc / 2351.12 pound container | Class II | Terminated |
| D-1414-2014 | 05-20-2014 | Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point. | West-Ward Pharmaceutical Corp. / a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles | Class II | Terminated |
| D-1548-2014 | 05-16-2014 | ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588 | Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL. | US Compounding Inc / 762 Syringes | Class II | Terminated |
| D-1386-2014 | 05-16-2014 | Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15. | Subpotent Drug. | Actavis Inc / 6913 packages | Class II | Terminated |
| D-1424-2014 | 05-16-2014 | Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20 Package NDCs: 0409-2267-20; 0409-2267-54; 0409-0125-01; 0409-0125-25 | Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution | Hospira Inc. / 45,448 vials | Class II | Terminated |
| D-1458-2014 | 05-15-2014 | Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14 | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Franck's Lab Inc dba Trinity Care Solutions / 31 units | Class II | Ongoing |
