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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1318-2016 | 04-20-2016 | Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 216 | Class II | Terminated |
| D-1301-2016 | 04-20-2016 | Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1200 | Class II | Terminated |
| D-1307-2016 | 04-20-2016 | Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 30 | Class II | Terminated |
| D-1351-2016 | 04-20-2016 | LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 178 boxes | Class II | Terminated |
| D-1284-2016 | 04-20-2016 | Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 10 | Class II | Terminated |
| D-1285-2016 | 04-20-2016 | Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 5 | Class II | Terminated |
| D-1315-2016 | 04-20-2016 | Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 215 | Class II | Terminated |
| D-1331-2016 | 04-20-2016 | Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 129 | Class II | Terminated |
| D-1273-2016 | 04-20-2016 | Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1303-2016 | 04-20-2016 | Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 70 | Class II | Terminated |
| D-1262-2016 | 04-20-2016 | Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 12 | Class II | Terminated |
| D-1274-2016 | 04-20-2016 | Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 225 | Class II | Terminated |
| D-1271-2016 | 04-20-2016 | Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1305-2016 | 04-20-2016 | HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 560 | Class II | Terminated |
| D-1260-2016 | 04-20-2016 | Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 650 syringes | Class II | Terminated |
| D-0924-2016 | 04-18-2016 | Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 5 bags | Class II | Terminated |
| D-0911-2016 | 04-18-2016 | 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 6 bags b) 1 bag c) 2 bags | Class II | Terminated |
| D-0946-2016 | 04-18-2016 | Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 54 bags | Class II | Terminated |
| D-0912-2016 | 04-18-2016 | 1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0913-2016 | 04-18-2016 | 70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 18 syringes | Class II | Terminated |
| D-0940-2016 | 04-18-2016 | Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0923-2016 | 04-18-2016 | Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 3 cassettes | Class II | Terminated |
| D-0939-2016 | 04-18-2016 | TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 86 bags | Class II | Terminated |
| D-0935-2016 | 04-18-2016 | Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 53 bags | Class II | Terminated |
| D-0930-2016 | 04-18-2016 | Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 15 bags, b) 15 bags, c) 15 bags, d) 4 bags | Class II | Terminated |
| D-0922-2016 | 04-18-2016 | Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 5 cassettes | Class II | Terminated |
| D-0937-2016 | 04-18-2016 | Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0945-2016 | 04-18-2016 | Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 88 bags | Class II | Terminated |
| D-0948-2016 | 04-18-2016 | Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 11 bags | Class II | Terminated |
| D-0917-2016 | 04-18-2016 | Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 16 bags | Class II | Terminated |
| D-0929-2016 | 04-18-2016 | Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 22 bags | Class II | Terminated |
| D-0927-2016 | 04-18-2016 | Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 3 bags | Class II | Terminated |
| D-0941-2016 | 04-18-2016 | Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 1 bag | Class II | Terminated |
| D-0925-2016 | 04-18-2016 | Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 10 bags, b) 23 bags, c) 9 bags, d) 6 bags | Class II | Terminated |
| D-0942-2016 | 04-18-2016 | Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 47 bags | Class II | Terminated |
| D-0928-2016 | 04-18-2016 | Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 24 bags | Class II | Terminated |
| D-0919-2016 | 04-18-2016 | Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 16 bags | Class II | Terminated |
| D-0915-2016 | 04-18-2016 | Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, Arkansas | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 11 bags | Class II | Terminated |
| D-0936-2016 | 04-18-2016 | Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 1 bag | Class II | Terminated |
| D-0921-2016 | 04-18-2016 | Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 14 bags | Class II | Terminated |
| D-0914-2016 | 04-18-2016 | Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 21 syringes | Class II | Terminated |
| D-0931-2016 | 04-18-2016 | Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0932-2016 | 04-18-2016 | Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 11 bags | Class II | Terminated |
| D-0920-2016 | 04-18-2016 | D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 6 bags | Class II | Terminated |
| D-0933-2016 | 04-18-2016 | Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 4 bags | Class II | Terminated |
| D-0918-2016 | 04-18-2016 | Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 32 bags | Class II | Terminated |
| D-0944-2016 | 04-18-2016 | Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 84 bags | Class II | Terminated |
| D-0947-2016 | 04-18-2016 | Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 2 bags | Class II | Terminated |
| D-0938-2016 | 04-18-2016 | TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0916-2016 | 04-18-2016 | Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 39 bags and b) 8 bags | Class II | Terminated |
| D-0943-2016 | 04-18-2016 | Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 59 bags | Class II | Terminated |
| D-0926-2016 | 04-18-2016 | Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 16 bags and b) 18 bags | Class II | Terminated |
| D-0838-2016 | 04-18-2016 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage. | VistaPharm, Inc. / 8,901 cases | Class II | Terminated |
| D-0934-2016 | 04-18-2016 | Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 14 bags | Class II | Terminated |
| D-0852-2016 | 04-12-2016 | Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87 Package NDCs: 10019-115-39; 10019-115-01; 10019-075-87; 10019-055-61 | Discoloration: presence of atypical yellow discoloration of the solution . | Baxter Healthcare Corp. / 11,630 babs | Class II | Terminated |
| D-0834-2016 | 04-12-2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01. Package NDCs: 63739-434-01; 63739-434-02 | Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. | Mckesson Packaging Services / 1,676 boxes | Class III | Terminated |
| D-0670-2017 | 04-08-2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA. | Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. | Jubilant Cadista Pharmaceuticals, Inc. / 81,077 bottles | Class III | Terminated |
| D-0671-2017 | 04-08-2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA. | Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. | Jubilant Cadista Pharmaceuticals, Inc. / 19,682 bottles | Class III | Terminated |
| D-0669-2017 | 04-08-2016 | BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA. | Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. | Jubilant Cadista Pharmaceuticals, Inc. / 20,882 bottles | Class III | Terminated |
| D-0818-2016 | 04-07-2016 | Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. Package NDCs: 63323-469-01; 63323-469-05; 63323-471-01; 63323-471-05 | Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. | Fresenius Kabi USA, LLC / 48,210 units | Class III | Terminated |
| D-0835-2016 | 04-07-2016 | Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00. | Presence of Particulate Matter | Akorn, Inc. / 10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles) | Class II | Terminated |
| D-1503-2016 | 04-06-2016 | Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03. Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 5,880 bottles | Class III | Terminated |
| D-1502-2016 | 04-06-2016 | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA. Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 20,556 bottles | Class III | Terminated |
| D-0819-2016 | 04-05-2016 | Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10 Package NDCs: 63323-416-01; 63323-416-05; 63323-417-01; 63323-417-10; 63323-418-01; 63323-418-20 | Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative. | Fresenius Kabi USA, LLC / 94,560 vials | Class II | Terminated |
| D-1052-2016 | 04-04-2016 | Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30 Package NDCs: 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01 | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Lupin Pharmaceuticals Inc. / 59,520 Bottles | Class III | Terminated |
| D-0853-2016 | 04-04-2016 | BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430. | Microbial Contamination of Non-Sterile Products: Failed S.aureus test. | Keystone Laboratories Inc / 7 Cases of 12 Bottles | Class II | Terminated |
| D-0918-2017 | 04-02-2016 | Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014 | Non-sterility - presence of bacteria confirmed by outside laboratory after day 14. | Complete Pharmacy and Medical Solutions LLC / 49 vials | Class I | Ongoing |
| D-0810-2016 | 03-31-2016 | Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30. | Failed Dissolution Specifications | Purdue Pharma L.P. / 2172 Cartons | Class III | Terminated |
| D-0910-2016 | 03-31-2016 | LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL | Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033 | Invisiblu International LLC / 3,319 bottles | Class II | Ongoing |
| D-0823-2016 | 03-31-2016 | Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33. | Labeling: Incorrect or Missing Lot and/or Exp Date | Amerisource Health Services / 5,034 cartons (151,020 capsules) | Class III | Terminated |
| D-0822-2016 | 03-31-2016 | Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33. | Labeling: Incorrect or Missing Lot and/or Exp Date | Amerisource Health Services / 228 cartons ( 4,560 capsules) | Class III | Terminated |
| D-0950-2016 | 03-31-2016 | ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5. | Subpotent Drug | Taro Pharmaceuticals U.S.A., Inc. / 62,800 Tubes | Class III | Terminated |
| D-0841-2016 | 03-30-2016 | Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30 | Failed Impurities/Degradation Specifications; 12 month stability time point | Dr. Reddy's Laboratories, Inc. / 50,280 bottles | Class II | Terminated |
| D-1066-2016 | 03-30-2016 | PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35. | Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe. | QuVa Pharma, Inc. / 20 cases | Class I | Terminated |
| D-1077-2016 | 03-25-2016 | All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1135-2016 | 03-25-2016 | All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1118-2016 | 03-25-2016 | All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1110-2016 | 03-25-2016 | All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1133-2016 | 03-25-2016 | All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1079-2016 | 03-25-2016 | All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1071-2016 | 03-25-2016 | All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1104-2016 | 03-25-2016 | All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1119-2016 | 03-25-2016 | All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1128-2016 | 03-25-2016 | All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1129-2016 | 03-25-2016 | All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1122-2016 | 03-25-2016 | All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1087-2016 | 03-25-2016 | All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1073-2016 | 03-25-2016 | All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1080-2016 | 03-25-2016 | All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1127-2016 | 03-25-2016 | All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1091-2016 | 03-25-2016 | All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1084-2016 | 03-25-2016 | All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1067-2016 | 03-25-2016 | All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1132-2016 | 03-25-2016 | All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1089-2016 | 03-25-2016 | All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1108-2016 | 03-25-2016 | All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1074-2016 | 03-25-2016 | All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1107-2016 | 03-25-2016 | All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1105-2016 | 03-25-2016 | All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
| D-1116-2016 | 03-25-2016 | All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy / N/A | Class II | Terminated |
