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-1380-2012 | 03-20-2012 | DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070 | Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level. | Quadrant Chemical Corporation / 4800 bottles | Class III | Terminated |
| D-1405-2012 | 03-16-2012 | Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08 | Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. | Ranbaxy Inc. / 2544 bottles | Class III | Terminated |
| D-1428-2012 | 03-14-2012 | Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10. | Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet. | Zydus Pharmaceuticals USA Inc / 1176 Bottles | Class II | Terminated |
| D-266-2013 | 03-10-2012 | Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS | Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug | The Menz Club, LLC / 50,000 capsules | Class I | Ongoing |
| D-041-2013 | 03-09-2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India | Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg | Aurobindo Pharma LTD / 23,616 bottles | Class II | Terminated |
| D-1422-2012 | 03-09-2012 | Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10. Package NDCs: 16571-411-10; 16571-412-10; 16571-412-50; 16571-413-05 | Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels. | Pack Pharmaceuticals / 4,848 bottles | Class III | Terminated |
| D-1398-2012 | 03-08-2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01 | Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point | Shionogi Inc. / 7230 bottles | Class II | Terminated |
| D-1395-2012 | 02-24-2012 | Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601. | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Lloyd Inc / 1,913,236 tablets | Class II | Terminated |
| D-1394-2012 | 02-24-2012 | Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601 | Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. | Lloyd Inc / 19,039 bottles | Class II | Terminated |
| D-1699-2012 | 02-23-2012 | Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328 | Marketed Without an Approved ANDA/NDA: presence of sildenafil. | www.vitaminbestbuy.com / 69 boxes | Class I | Terminated |
| D-1700-2012 | 02-23-2012 | Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY | Marketed Without an Approved ANDA/NDA: presence of sibutramine | www.vitaminbestbuy.com / 52 boxes | Class I | Terminated |
| D-1698-2012 | 02-23-2012 | Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet | Marketed Without an Approved ANDA/NDA: presence of sildenafil | www.vitaminbestbuy.com / 550 boxes | Class I | Terminated |
| D-221-2013 | 02-20-2012 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08 | Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. | Physicians Total Care, Inc. / 1200 capsules | Class II | Terminated |
| D-222-2013 | 02-20-2012 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09 | Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. | Physicians Total Care, Inc. / 3660 capsules | Class II | Terminated |
| D-1389-2012 | 02-08-2012 | Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0 | Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. | Physicians Total Care, Inc. / 3 bottles | Class II | Terminated |
| D-1407-2012 | 02-06-2012 | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 | CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices. | sanofi-aventis US, Inc. / 196,355 vials | Class II | Terminated |
| D-1408-2012 | 02-06-2012 | Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20 | CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices. | sanofi-aventis US, Inc. / 387,738 vials | Class II | Terminated |
| D-1393-2012 | 02-03-2012 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Lloyd Inc / 19,166 bottles | Class II | Terminated |
| D-1392-2012 | 02-03-2012 | Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. | Lloyd Inc / 1,924,297 bulk tablets | Class II | Terminated |
| D-265-2013 | 12-19-2011 | Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA | Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction | Body Basics Inc / 30,000 capsules | Class I | Terminated |
| D-1429-2012 | 12-02-2011 | Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA | A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified. | Eagle Pharmaceuticals Inc. / 19,660 vials | Class I | Terminated |
| D-1652-2012 | 11-10-2011 | Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01. | Misbranded | Victus, Inc. / 1,535 Tubes | Class II | Terminated |
| D-1674-2012 | 11-08-2011 | ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA | Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging. | Carefusion 213, Llc / 67,775 Applicators | Class II | Terminated |
| D-1418-2012 | 10-17-2011 | Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30 | Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP. | Meda Pharmaceuticals Inc. / 478,569 Softgel Capsules (172,740 trade plus 305,829 samples). | Class II | Terminated |
| D-1440-2012 | 09-30-2011 | Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 | Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume. | VistaPharm, Inc. / 27,221 unit dose cups | Class II | Terminated |
| D-1450-2014 | 09-27-2011 | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01 Package NDCs: 53746-271-50; 53746-271-01; 53746-271-05; 53746-271-10; 53746-272-11; 53746-272-24; 53746-272-01; 53746-272-02; 53746-272-05 | Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg | Shamrock Medical Solutions Group LLC / 284/800 mg tablets | Class II | Terminated |
| D-1447-2014 | 09-27-2011 | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36 | Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL | Shamrock Medical Solutions Group LLC / 55/1 mL/20mg/mL syringe | Class I | Terminated |
| D-1451-2014 | 09-27-2011 | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60 | Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg | Shamrock Medical Solutions Group LLC / 99/240 mg softgel caps | Class II | Terminated |
| D-1446-2014 | 09-27-2011 | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90 | Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules | Shamrock Medical Solutions Group LLC / 89/120 mg tablets | Class I | Terminated |
| D-1449-2014 | 09-27-2011 | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01 | Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets | Shamrock Medical Solutions Group LLC / 99/500 mg tablets | Class II | Terminated |
| D-1448-2014 | 09-27-2011 | metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01 | Labeling: Label Mix up; product labeled did not indicated Extended Release | Shamrock Medical Solutions Group LLC / 88/5 mg tablets | Class I | Terminated |
| D-1379-2012 | 09-19-2011 | Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146. | Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets. | Physicians Total Care, Inc. / a) 4 bottles; b) 2 bottles | Class II | Terminated |
| D-1370-2012 | 07-06-2011 | Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15 | Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point. | Bausch & Lomb, Inc. / 59,777 bottles | Class II | Terminated |
| D-1374-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 244,320 patches | Class II | Terminated |
| D-1375-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186. | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 335,190 patches | Class II | Terminated |
| D-1373-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186. | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 242,100 patches | Class II | Terminated |
| D-1372-2012 | 07-05-2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3; 54092-554-30 | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 357,510 patches | Class II | Terminated |
| D-1446-2012 | 06-22-2011 | Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60. Package NDCs: 0487-9501-25; 0487-9501-03; 0487-9501-60; 0487-9501-01 | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. / 56,028 cartons | Class II | Terminated |
| D-1667-2012 | 06-15-2011 | Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5. Package NDCs: 60505-0833-5 | CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product. | Apotex Corp. / 963,407 bottles | Class III | Terminated |
| D-196-2013 | 05-27-2011 | ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090 | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. / 912 bottles | Class II | Terminated |
| D-194-2013 | 05-27-2011 | PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090 | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. / 2980 bottles | Class II | Terminated |
| D-195-2013 | 05-27-2011 | PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090 | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. | A B Nutrition, Inc. / 509 bottles | Class II | Terminated |
| D-301-2013 | 05-23-2011 | Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD. | Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form. | Physicians Total Care, Inc. / 1 bottle | Class III | Terminated |
| D-091-2013 | 04-08-2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1. | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. | Physicians Total Care, Inc. / 9 bottles | Class III | Terminated |
| D-090-2013 | 04-08-2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1. | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. | Physicians Total Care, Inc. / 5 bottles | Class III | Terminated |
| D-092-2013 | 04-08-2011 | Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1. | Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. | Physicians Total Care, Inc. / 5 Bottles | Class III | Terminated |
| D-547-2013 | 04-06-2011 | Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. | Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications. | Physicians Total Care, Inc. / 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles | Class II | Terminated |
| D-1658-2012 | 04-06-2011 | Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50 | Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume | VistaPharm, Inc. / N/A | Class II | Terminated |
| D-1391-2012 | 03-18-2011 | Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03 | Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life | Physicians Total Care, Inc. / 60 bottles | Class II | Terminated |
| D-1378-2012 | 03-15-2011 | CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967. | Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. | Luitpold Pharmaceuticals, Inc. / 30 mL: 2,078,800 vials; 100 mL: 167,100 vials | Class II | Terminated |
| D-011-2013 | 02-10-2011 | Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321. | Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover). | Abc Compounding Company Inc / 66 rolls of wipes | Class III | Terminated |
| D-317-2013 | 02-08-2011 | Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146. | Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). | Physicians Total Care, Inc. / 60 tablets | Class III | Terminated |
| D-1669-2012 | 01-19-2011 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771 | Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," | VistaPharm, Inc. / 73,800 cups | Class III | Terminated |
| D-1386-2012 | 11-10-2010 | Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00 | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Physicians Total Care, Inc / 600 tablets (5 containers of 120 tablets each) | Class I | Terminated |
| D-1385-2012 | 11-10-2010 | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Physicians Total Care, Inc / 540 tablets (9 containers of 60 tablets each) | Class I | Terminated |
| D-093-2013 | 10-04-2010 | Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1. | Presence of Particulate Matter: glass delamination | Physicians Total Care, Inc. / 20 vials | Class II | Terminated |
| D-192-2013 | 03-01-2010 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072. | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone. | K C Pharmaceuticals Inc / 31,704 bottles | Class II | Terminated |
| D-1661-2012 | 06-14-2007 | Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9 Package NDCs: 60505-2502-1; 60505-2502-2; 60505-2502-3; 60505-2503-1; 60505-2503-2; 60505-2503-3 | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. | Apotex Corp. / 3063 | Class II | Terminated |
| D-1662-2012 | 06-14-2007 | Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3 Package NDCs: 60505-2502-1; 60505-2502-2; 60505-2502-3; 60505-2503-1; 60505-2503-2; 60505-2503-3 | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. | Apotex Corp. / 31 | Class II | Terminated |
| D-040-2013 | 02-24-2006 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. | Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. | Merit Medical Systems, Inc / 2470 kits | Class I | Terminated |
