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-0994-2015 | 11-03-2014 | Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein | REFA Enterprises, LLC / 92 bottles | Class I | Terminated |
| D-0276-2015 | 10-30-2014 | Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03 Package NDCs: 0338-0431-03; 0338-0433-04; 0338-0424-18; 0338-0428-12 | Subpotent Drug: Heparin raw material was found to have low potency | Baxter Healthcare Corp. / 127,746 Viaflex Plus Container | Class II | Terminated |
| D-0298-2015 | 10-24-2014 | Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25 | Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate. | CareFusion 213, LLC / 20,556,000 scrubs | Class III | Terminated |
| D-0303-2015 | 10-24-2014 | Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01 | Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility. | Hospira Inc. / 261,706 vials | Class II | Terminated |
| D-0249-2015 | 10-22-2014 | Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. | Prometheus Laboratories Inc. / 16,296 bottles (60-count), 5,166 bottles (250-count) | Class II | Terminated |
| D-0049-2015 | 10-21-2014 | Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3. Package NDCs: 51672-4041-1; 51672-4041-2; 51672-4041-9; 51672-4041-0; 51672-4050-1; 51672-4005-1; 51672-4005-2; 51672-4005-3; 51672-4123-6; 51672-4123-1; 51672-4123-3; 51672-4124-6; 51672-4124-1; 51672-4124-3; 51672-4125-6; 51672-4125-1; 51672-4125-3; 51672-4047-9; 51672-4047-4 | Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval. | Taro Pharmaceuticals U.S.A., Inc. / 1,966 bottles | Class III | Terminated |
| D-0238-2015 | 10-20-2014 | Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ | cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1. | Nanophase Technologies Corporation / 1,596 Kg | Class III | Terminated |
| D-0234-2015 | 10-17-2014 | Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36 Package NDCs: 62032-912-01; 62032-101-36; 62032-100-36; 62032-140-09; 3620321013 | Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte. | Obagi Medical Products / 975 bottles | Class II | Terminated |
| D-0330-2015 | 10-17-2014 | Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5. Package NDCs: 16714-661-01; 16714-661-02; 16714-661-03; 16714-662-01; 16714-662-02; 16714-662-03; 16714-663-01; 16714-663-02 | Failed Tablet/Capsule Specifications: Complaints of empty capsules received. | Aurobindo Pharma USA Inc / 24,816 bottles | Class II | Terminated |
| D-0391-2015 | 10-16-2014 | 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045 Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01 | Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper. | Hospira Inc. / 100,100 units | Class I | Terminated |
| D-0242-2015 | 10-16-2014 | Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. | Apotex Inc. / 18,493 | Class III | Terminated |
| D-0240-2015 | 10-16-2014 | Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10 | Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point. | Pharmaceutical Associates Inc / 9,640 unit dose cups | Class II | Terminated |
| D-0241-2015 | 10-16-2014 | Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. | Apotex Inc. / 13,177 bottles | Class III | Terminated |
| D-0244-2015 | 10-16-2014 | Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. | Apotex Inc. / 22,710 bottles | Class III | Terminated |
| D-0243-2015 | 10-16-2014 | Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. | Apotex Inc. / 11,062 bottles | Class III | Terminated |
| D-0283-2015 | 10-14-2014 | Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 6,193,416 bags | Class II | Terminated |
| D-0277-2015 | 10-14-2014 | Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 152,172 bags | Class II | Terminated |
| D-0285-2015 | 10-14-2014 | 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 16,487,040 bags | Class II | Terminated |
| D-0286-2015 | 10-14-2014 | 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 784,920 bags | Class II | Terminated |
| D-0281-2015 | 10-14-2014 | Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 275,448 bags | Class II | Terminated |
| D-0287-2015 | 10-14-2014 | Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 153,504 bags | Class II | Terminated |
| D-0278-2015 | 10-14-2014 | Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 836,460 bags | Class II | Terminated |
| D-0279-2015 | 10-14-2014 | 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 301,560 bags | Class II | Terminated |
| D-0280-2015 | 10-14-2014 | 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 823,296 bags | Class II | Terminated |
| D-0284-2015 | 10-14-2014 | Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 305,664 bags | Class II | Terminated |
| D-0282-2015 | 10-14-2014 | 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09. | Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks. | Hospira Inc. / 340,272 bags | Class II | Terminated |
| D-0309-2015 | 10-14-2014 | Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141 | Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products. | Vann Healthcare Services Inc / 1 vial | Class II | Terminated |
| D-0310-2015 | 10-14-2014 | Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141 | Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products. | Vann Healthcare Services Inc / 410 syringes | Class II | Terminated |
| D-0312-2015 | 10-14-2014 | Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141 | Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products. | Vann Healthcare Services Inc / 7 vials | Class II | Terminated |
| D-0311-2015 | 10-14-2014 | Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141 | Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products. | Vann Healthcare Services Inc / 900 syringes | Class II | Terminated |
| D-0248-2015 | 10-10-2014 | Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320 | Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP | Contract Packaging Resources Inc. / 11,640 boxes | Class II | Terminated |
| D-0235-2015 | 10-10-2014 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01. Package NDCs: 0008-1179-01; 0008-1279-01; 0008-1125-01 | Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue. | Pfizer Inc. / 16,000 kits | Class III | Terminated |
| D-0043-2015 | 10-10-2014 | MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11 Package NDCs: 68084-149-11; 68084-149-01 | Subpotent; 6 month stability time point | American Health Packaging / 2,005 cartons | Class III | Terminated |
| D-0046-2015 | 10-09-2014 | GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540 Package NDCs: 42571-100-01; 42571-100-05; 42571-101-01; 42571-101-05; 42571-102-01; 42571-102-05; 42571-103-01; 42571-103-05; 42571-104-01; 42571-104-05; 42571-105-01; 42571-105-05 | Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing. | Micro Labs Usa, Inc S / 11,328 bottles | Class II | Terminated |
| D-0050-2015 | 10-08-2014 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. | Teva Pharmaceuticals USA / 19,545 Bottles | Class II | Terminated |
| D-0041-2015 | 10-07-2014 | ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528 | Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label. | Zee Medical Products Inc / 43,752 boxes | Class II | Terminated |
| D-0213-2015 | 10-06-2014 | PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 46.7 mL | Class II | Terminated |
| D-0193-2015 | 10-06-2014 | GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 300 mL | Class II | Terminated |
| D-0191-2015 | 10-06-2014 | GANCICLOVIR, preservative free, 0.2mg/0.05mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 20 Syringes | Class II | Terminated |
| D-0176-2015 | 10-06-2014 | ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 7900 mL | Class II | Terminated |
| D-0204-2015 | 10-06-2014 | METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 119/0.3 mL vials and 106/1 mL vials | Class II | Terminated |
| D-0198-2015 | 10-06-2014 | HYDROXOCOBALAMIN-preservative free (B12), 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 58 mL | Class II | Terminated |
| D-0221-2015 | 10-06-2014 | PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 660 mL | Class II | Terminated |
| D-0175-2015 | 10-06-2014 | ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 2500 mL | Class II | Terminated |
| D-0222-2015 | 10-06-2014 | SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 180 mL | Class II | Terminated |
| D-0219-2015 | 10-06-2014 | PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 10 mL | Class II | Terminated |
| D-0208-2015 | 10-06-2014 | OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 680 mL | Class II | Terminated |
| D-0187-2015 | 10-06-2014 | DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 280 mL | Class II | Terminated |
| D-0201-2015 | 10-06-2014 | LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles | Class II | Terminated |
| D-0206-2015 | 10-06-2014 | MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 5 mL | Class II | Terminated |
| D-0216-2015 | 10-06-2014 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.. | Oregon Compounding Centers, Inc. dba Creative Compounds / 103.4 mL | Class II | Terminated |
| D-0192-2015 | 10-06-2014 | GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 800 mL | Class II | Terminated |
| D-0182-2015 | 10-06-2014 | CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 117 vials | Class II | Terminated |
| D-0210-2015 | 10-06-2014 | PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 43 mL | Class II | Terminated |
| D-0212-2015 | 10-06-2014 | PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 10 mL | Class II | Terminated |
| D-0197-2015 | 10-06-2014 | HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 10 mL | Class II | Terminated |
| D-0227-2015 | 10-06-2014 | VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 12 syringes | Class II | Terminated |
| D-0223-2015 | 10-06-2014 | TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 175 mL | Class II | Terminated |
| D-0173-2015 | 10-06-2014 | ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 5 mL | Class II | Terminated |
| D-0225-2015 | 10-06-2014 | TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection | Oregon Compounding Centers, Inc. dba Creative Compounds / 1000 mL | Class II | Terminated |
| D-0179-2015 | 10-06-2014 | CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 580 mL | Class II | Terminated |
| D-0181-2015 | 10-06-2014 | CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 145 vials | Class II | Terminated |
| D-0203-2015 | 10-06-2014 | METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 516 mL | Class II | Terminated |
| D-0184-2015 | 10-06-2014 | COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 600 mL | Class II | Terminated |
| D-0228-2015 | 10-06-2014 | VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 490 mL | Class II | Terminated |
| D-0195-2015 | 10-06-2014 | GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 2200 mL | Class II | Terminated |
| D-0186-2015 | 10-06-2014 | DEXPANTHENOL with preservative, 250 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 210 mL | Class II | Terminated |
| D-0189-2015 | 10-06-2014 | ESTRADIOL CYPIONATE (COMPOUNDED/GRAPESEED OIL), 5 mg/mL, injectable, 1 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 4 mL | Class II | Terminated |
| D-0214-2015 | 10-06-2014 | PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 5 mL | Class II | Terminated |
| D-0194-2015 | 10-06-2014 | GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 250 mL | Class II | Terminated |
| D-0200-2015 | 10-06-2014 | HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 520 mL | Class II | Terminated |
| D-0220-2015 | 10-06-2014 | PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 540 mL | Class II | Terminated |
| D-0202-2015 | 10-06-2014 | METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 120 mL | Class II | Terminated |
| D-0174-2015 | 10-06-2014 | ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 5 mL | Class II | Terminated |
| D-0205-2015 | 10-06-2014 | METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 1320 mL | Class II | Terminated |
| D-0215-2015 | 10-06-2014 | PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 15 mL | Class II | Terminated |
| D-0217-2015 | 10-06-2014 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 10 mL | Class II | Terminated |
| D-0207-2015 | 10-06-2014 | MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 8 mL | Class II | Terminated |
| D-0209-2015 | 10-06-2014 | PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 25 mL | Class II | Terminated |
| D-0190-2015 | 10-06-2014 | GANCICLOVIR -preservative free, 2mg/0.1mL, injectable, 0.1 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 40 syringes | Class II | Terminated |
| D-0185-2015 | 10-06-2014 | DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 4 mL | Class II | Terminated |
| D-0188-2015 | 10-06-2014 | EPINEPHRINE/WATER, preservative free 1:1000, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 10 mL | Class II | Terminated |
| D-0218-2015 | 10-06-2014 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 1.7 mL | Class II | Terminated |
| D-0183-2015 | 10-06-2014 | CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 900 mL | Class II | Terminated |
| D-0196-2015 | 10-06-2014 | GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 900 mL | Class II | Terminated |
| D-0178-2015 | 10-06-2014 | BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 2.65 mL | Class II | Terminated |
| D-0211-2015 | 10-06-2014 | PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 5 mL | Class II | Terminated |
| D-0199-2015 | 10-06-2014 | HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 570 mL | Class II | Terminated |
| D-0224-2015 | 10-06-2014 | TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 85 mL | Class II | Terminated |
| D-0177-2015 | 10-06-2014 | AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 5483/0.5 mL syringes | Class II | Terminated |
| D-0226-2015 | 10-06-2014 | TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 2 syringes | Class II | Terminated |
| D-0180-2015 | 10-06-2014 | CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070 | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds / 12 syringes | Class II | Terminated |
| D-0389-2015 | 10-06-2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Hospira Inc. / 2,500 vials | Class I | Terminated |
| D-0387-2015 | 10-06-2014 | Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01. Package NDCs: 0409-6531-12; 0409-6531-02; 0409-6533-11; 0409-6533-01; 0409-6533-21; 0409-4332-11; 0409-4332-01; 0409-3515-11; 0409-3515-01 | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Hospira Inc. / 200 vials | Class II | Terminated |
| D-0388-2015 | 10-06-2014 | Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01. Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25 | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Hospira Inc. / 100 vials | Class II | Terminated |
| D-0390-2015 | 10-06-2014 | Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01. Package NDCs: 0409-6531-12; 0409-6531-02; 0409-6533-11; 0409-6533-01; 0409-6533-21; 0409-4332-11; 0409-4332-01; 0409-3515-11; 0409-3515-01 | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Hospira Inc. / 90,600 vials | Class II | Terminated |
| D-0027-2015 | 10-03-2014 | Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 Package NDCs: 25021-700-01; 25021-701-01; 25021-701-02 | Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date. | Sagent Pharmaceuticals Inc / 69,050 vials | Class II | Terminated |
| D-0047-2015 | 10-03-2014 | CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1 | Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth. | Wisconsin Pharmacal Company / 20,032 bottles | Class II | Terminated |
| D-0026-2015 | 10-02-2014 | Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15 | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point | Valeant Pharmaceuticals International / 1663 tubes | Class III | Terminated |
| D-0025-2015 | 10-02-2014 | Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15 | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point | Valeant Pharmaceuticals International / 34,218 tubes | Class III | Terminated |
