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 October 10, 2025 and include a total of 17129 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1139-2017 | 08-17-2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance | VistaPharm, Inc. / 3084 bottles | Class III | Terminated |
| D-0148-2018 | 08-17-2017 | All Sterile Products within expiry | Lack of Assurance of Sterility . | Vital Rx, Inc. dba Atlantic Pharmacy and Compounding / 61 Products | Class II | Terminated |
| D-0224-2018 | 08-16-2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-0227-2018 | 08-16-2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-0226-2018 | 08-16-2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-0225-2018 | 08-16-2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-1157-2017 | 08-15-2017 | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 6 bottles | Class II | Terminated |
| D-1124-2017 | 08-15-2017 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00 | Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. | Amphastar Pharmaceuticals, Inc. / 637,810 vials | Class II | Terminated |
| D-1151-2017 | 08-15-2017 | B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 45 vials | Class II | Terminated |
| D-1156-2017 | 08-15-2017 | Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 6 bottles | Class II | Terminated |
| D-1152-2017 | 08-15-2017 | Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 7 vials | Class II | Terminated |
| D-1148-2017 | 08-15-2017 | Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 10 vials | Class II | Terminated |
| D-1147-2017 | 08-15-2017 | Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 30 vials | Class II | Terminated |
| D-1158-2017 | 08-15-2017 | Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 20 vials | Class II | Terminated |
| D-1155-2017 | 08-15-2017 | MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1153-2017 | 08-15-2017 | Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1160-2017 | 08-15-2017 | Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 2,334 syringes | Class II | Terminated |
| D-1149-2017 | 08-15-2017 | G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 3 vials | Class II | Terminated |
| D-1159-2017 | 08-15-2017 | Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 644 vials | Class II | Terminated |
| D-1146-2017 | 08-15-2017 | PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 82 vials | Class II | Terminated |
| D-1150-2017 | 08-15-2017 | Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1161-2017 | 08-15-2017 | BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 200 syringes | Class II | Terminated |
| D-1154-2017 | 08-15-2017 | L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1118-2017 | 08-11-2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940 Package NDCs: 55289-791-07; 55289-791-14; 55289-791-15; 55289-791-21; 55289-791-28; 55289-791-30; 55289-791-60 | Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test . | PD-Rx Pharmaceuticals, Inc. / 3440 bottles | Class III | Terminated |
| D-1125-2017 | 08-10-2017 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00. | Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product. | Morton Grove Pharmaceuticals, Inc. / 7332 bottles | Class II | Terminated |
| D-0140-2018 | 08-10-2017 | Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0136-2018 | 08-10-2017 | Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0143-2018 | 08-10-2017 | Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0142-2018 | 08-10-2017 | Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0141-2018 | 08-10-2017 | Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0138-2018 | 08-10-2017 | Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0139-2018 | 08-10-2017 | HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0137-2018 | 08-10-2017 | Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0144-2018 | 08-10-2017 | Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0145-2018 | 08-10-2017 | Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0129-2018 | 08-10-2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15 | Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data. | Premier Pharmacy Labs Inc / 1610 syringes | Class II | Terminated |
| D-0102-2018 | 08-07-2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16 | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg. | International Laboratories, Inc. / 82056 bottles | Class I | Terminated |
| D-1129-2017 | 08-04-2017 | Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09 | Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label. | Degasa Sa De Cv / 720 bottles | Class II | Terminated |
| D-1164-2017 | 08-04-2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-25. | Failed Dissolution Specifications | Pfizer Inc. / 11,790 bottles | Class III | Terminated |
| D-1163-2017 | 08-04-2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20. | Failed Dissolution Specifications | Pfizer Inc. / 14,712 bottles | Class III | Terminated |
| D-1086-2017 | 08-04-2017 | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01 Package NDCs: 59676-303-00; 59676-303-01; 59676-304-00; 59676-304-01; 59676-310-00; 59676-310-01; 59676-310-02; 59676-302-00; 59676-302-01; 59676-340-00; 59676-340-01; 59676-312-00; 59676-312-04; 59676-320-00; 59676-320-04 | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. | Amgen, Inc. / 175,632 vials | Class II | Terminated |
| D-1138-2017 | 08-03-2017 | Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16 | Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment. | MEDLINE INDUSTRIES INC / 462 cases, 144 packets per case | Class II | Terminated |
| D-0120-2018 | 08-03-2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84 Package NDCs: 65162-687-84 | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. | Amneal Pharmaceuticals of New York, LLC / 136376 bottles | Class I | Terminated |
| D-1083-2017 | 08-03-2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940 Package NDCs: 10702-026-03; 10702-026-01; 10702-026-10; 10702-027-03; 10702-027-01; 10702-027-10; 10702-028-03; 10702-028-01; 10702-028-10 | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test. | KVK-Tech, Inc. / 35,267 bottles | Class III | Terminated |
| D-1058-2017 | 08-02-2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15 | Failed Moisture Limits: out of specification test results for water content obtained during stability testing. | Teva Pharmaceuticals USA / 2,880 cartons (30 unit dose blister pack per carton) | Class III | Terminated |
| D-1122-2017 | 08-02-2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 4,715 bottles | Class II | Terminated |
| D-1121-2017 | 08-02-2017 | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 26,891 bottles | Class II | Terminated |
| D-1123-2017 | 08-02-2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 32,413 bottles | Class II | Terminated |
| D-1119-2017 | 08-02-2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 7,308 bottles | Class II | Terminated |
| D-1120-2017 | 08-02-2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 7,272 bottles | Class II | Terminated |
| D-0126-2018 | 08-01-2017 | NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities. | The Ampt Life, LLC / 1380 packets | Class I | Terminated |
| D-1057-2017 | 07-28-2017 | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30 | Failed Tablet/Capsule Specification: out of specification for tablet weight. | PD-Rx Pharmaceuticals, Inc. / 100 bottles | Class II | Terminated |
| D-1091-2017 | 07-26-2017 | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09 | Presence of Particulate Matter; stainless steel | ICU Medical Inc / 436,716 flexible containers | Class II | Terminated |
| D-1080-2017 | 07-26-2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01 Package NDCs: 0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01 | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST / 14,300 vials | Class II | Terminated |
| D-1082-2017 | 07-26-2017 | Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. Package NDCs: 0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01 | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST / 56,340 vials | Class II | Terminated |
| D-1081-2017 | 07-26-2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50 Package NDCs: 0409-2634-10; 0409-2634-01; 0409-2634-25; 0409-2634-05; 0409-2634-50 | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST / 9,009 vials | Class II | Terminated |
| D-1039-2017 | 07-25-2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53. | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA / 401,750 cartons | Class III | Terminated |
| D-0121-2018 | 07-24-2017 | LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health. | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs. | EZWeightLossTX LLC / 4958 bottles | Class I | Terminated |
| D-1056-2017 | 07-24-2017 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60 Package NDCs: 0172-5728-60; 0172-5728-70; 0172-5728-80; 0172-5729-60; 0172-5729-70 | Failed Tablet/Capsule Specification; out of specification for tablet weight | Teva Pharmaceuticals USA / 28,188 bottles | Class II | Terminated |
| D-0122-2018 | 07-24-2017 | LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health. | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs. | EZWeightLossTX LLC / 1424 bottles | Class I | Terminated |
| D-1145-2017 | 07-21-2017 | Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY | Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil | Chiavna Saffron LLC / 211 bottles; 339 boxes | Class I | Terminated |
| D-1095-2017 | 07-20-2017 | Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30 Package NDCs: 31722-833-30; 31722-833-90; 31722-833-31; 31722-833-32; 31722-834-30; 31722-834-90; 31722-834-31; 31722-834-32 | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. | Hetero USA Inc / 5664 bottles | Class II | Terminated |
| D-1094-2017 | 07-19-2017 | Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12 | Failed impurities/degradation specifications: Out of specification for a related compound C. | AVKARE Inc. / 1172 cartons (23440 tablets) | Class III | Terminated |
| D-1103-2017 | 07-17-2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1107-2017 | 07-17-2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1144-2017 | 07-17-2017 | New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected] | Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. | BESTHERBS COFFEE LLC / 6,250 packets | Class I | Terminated |
| D-1099-2017 | 07-17-2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 73 balms | Class III | Terminated |
| D-1097-2017 | 07-17-2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 478 balms | Class III | Terminated |
| D-1105-2017 | 07-17-2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1108-2017 | 07-17-2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033200. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1101-2017 | 07-17-2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1102-2017 | 07-17-2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1106-2017 | 07-17-2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1110-2017 | 07-17-2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1098-2017 | 07-17-2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 105 creams | Class III | Terminated |
| D-1104-2017 | 07-17-2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1054-2017 | 07-17-2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magnesium Citrate, UPC# 308690686383, NDC 0869-686-38, Distributed by: Vi-Jon, Smyrna, TN, 37167 ; d) ShopRite Magnesium Citrate Oral Solution Saline Laxative Low Sodium, UPC# 041190211487, NDC 41190-686-38, Distributed by: Wakefern Food Corporation, Jamesburg, NJ 08831 | Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis. | Vi-Jon, Inc. / 101,244 bottles | Class II | Terminated |
| D-1100-2017 | 07-17-2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 373 creams | Class III | Terminated |
| D-1109-2017 | 07-17-2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1001-2017 | 07-14-2017 | ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 108 bags | Class II | Terminated |
| D-1031-2017 | 07-14-2017 | PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1000-2017 | 07-14-2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 130 bags | Class II | Terminated |
| D-1034-2017 | 07-14-2017 | fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1025-2017 | 07-14-2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1015-2017 | 07-14-2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1012-2017 | 07-14-2017 | fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1016-2017 | 07-14-2017 | fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1010-2017 | 07-14-2017 | fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1009-2017 | 07-14-2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1074-2017 | 07-14-2017 | Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12 | Lack of Sterility Assurance. | Cantrell Drug Company / 46078 syringes | Class II | Terminated |
| D-1069-2017 | 07-14-2017 | Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15 | Lack of Sterility Assurance. | Cantrell Drug Company / 18015 syringes | Class II | Terminated |
| D-1004-2017 | 07-14-2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32. | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. | SCA Pharmaceuticals / 2 bags | Class II | Terminated |
| D-1022-2017 | 07-14-2017 | NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1030-2017 | 07-14-2017 | PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1011-2017 | 07-14-2017 | fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1029-2017 | 07-14-2017 | PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1020-2017 | 07-14-2017 | NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1026-2017 | 07-14-2017 | PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
| D-1072-2017 | 07-14-2017 | Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18 | Lack of Sterility Assurance. | Cantrell Drug Company / 3039 bags | Class II | Terminated |
| D-1027-2017 | 07-14-2017 | PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40 | Lack of Assurance of Sterility; product has the potential to leak. | SCA Pharmaceuticals / N/A | Class II | Terminated |
