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 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0157-2016 | 10-06-2015 | METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0159-2016 | 10-06-2015 | CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0156-2016 | 10-06-2015 | PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0160-2016 | 10-06-2015 | TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0158-2016 | 10-06-2015 | TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0675-2016 | 10-05-2015 | NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827. | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. | Inaffit, LLC / 6000 Bottles | Class I | Terminated |
| D-0670-2016 | 10-01-2015 | Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | MSNV, Inc dba National Video Supply / 868 Bottles | Class I | Terminated |
| D-0671-2016 | 10-01-2015 | Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | MSNV, Inc dba National Video Supply / 460 Blister Packs | Class I | Terminated |
| D-0016-2016 | 10-01-2015 | Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. | Tribute Pharmaceuticals US Inc. / 39,650 bottles | Class III | Terminated |
| D-0017-2016 | 10-01-2015 | Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA. | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. | Tribute Pharmaceuticals US Inc. / 140,607 bottles | Class III | Terminated |
| D-0672-2016 | 09-30-2015 | Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | Premiere Sales Group / 337 bottles | Class I | Terminated |
| D-0673-2016 | 09-30-2015 | Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | Premiere Sales Group / | Class I | Terminated |
| D-0722-2016 | 09-29-2015 | Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1. | Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug. | Fit Firm and Fabulous / 3000 bottles | Class I | Terminated |
| D-0054-2016 | 09-29-2015 | Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29 | Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing. | Hospira Inc. / 24,100 Syringes | Class III | Ongoing |
| D-0525-2016 | 09-28-2015 | Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026) Package NDCs: 41163-458-39; 41163-458-66; 41163-458-72; 41163-458-76; 41163-458-95; 41163-458-58; 24385-998-74; 24385-998-65; 24385-998-75; 24385-998-58; 55910-699-66; 42507-458-30; 42507-458-39; 42507-458-66; 42507-458-60; 42507-458-72; 42507-458-45; 42507-458-95; 42507-458-90; 42507-458-75; 42507-458-06; 42507-458-00; 42507-458-87; 59779-458-13; 59779-458-39; 59779-458-95; 59779-458-75; 59779-458-76; 59779-458-88; 59779-458-66; 59779-458-72; 59779-458-70; 59779-458-58; 59779-458-06; 59779-458-00; 59779-458-05; 59779-458-01; 36800-458-13; 36800-458-66; 36800-458-39; 36800-458-95; 36800-458-72; 36800-458-75; 36800-458-47; 36800-458-87; 36800-458-06; 36800-458-58; 37808-458-66; 3700306594; 49738-458-66; 30142-458-66; 49781-106-14; 55316-458-66; 21130-458-66; 0363-0495-66; 46994-458-66; 41520-458-66; 41190-458-66; 0411902233; 37012-458-66; 3700306776; 55312-458-66; 0154001210 | Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester | Perrigo Company PLC / 209,256 cartons | Class III | Terminated |
| D-0014-2016 | 09-25-2015 | Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3. | Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. | Actavis Laboratories, FL, Inc. / 13,284 bottles | Class II | Terminated |
| D-0011-2016 | 09-25-2015 | FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8. Package NDCs: 0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46 | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. | Boehringer Ingelheim Roxane Inc / 11,110 bottles | Class III | Terminated |
| D-0012-2016 | 09-25-2015 | FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2. Package NDCs: 0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46 | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. | Boehringer Ingelheim Roxane Inc / 5,160 bottles | Class III | Terminated |
| D-0771-2016 | 09-25-2015 | RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. | Tf Supplements / 350 Bottles | Class I | Terminated |
| D-0772-2016 | 09-25-2015 | Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748 | Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. | Tf Supplements / 128 Blister Packs | Class I | Terminated |
| D-0662-2016 | 09-25-2015 | ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30. | Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. | Medline Industries Inc / 7,372 HDPE Bottles | Class I | Terminated |
| D-0663-2016 | 09-25-2015 | ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30. | Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. | Medline Industries Inc / | Class I | Terminated |
| D-0161-2016 | 09-24-2015 | Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01 Package NDCs: 0009-0029-01; 0009-0029-46; 0009-0029-02; 0009-0029-14; 0009-0055-01; 0009-0055-46; 0009-0055-03; 0009-0055-15; 0009-0090-01; 0009-0090-04; 0009-0090-13; 0009-0094-01; 0009-0094-03 | Subpotent Drug | Pfizer Inc. / 21,120 HDPE bottles | Class II | Terminated |
| D-0006-2016 | 09-23-2015 | Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527 | Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance. | Diabetes Corporation of America dba DCA Pharmacy / 129 vials | Class II | Terminated |
| D-0879-2016 | 09-23-2015 | Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown | Class I | Terminated |
| D-0880-2016 | 09-23-2015 | Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown | Class I | Terminated |
| D-0881-2016 | 09-23-2015 | Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Lucy's Weight Loss (dba. Waisted With Lucy) / N/A | Class I | Terminated |
| D-0047-2016 | 09-22-2015 | Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 2 vial | Class II | Terminated |
| D-0044-2016 | 09-22-2015 | Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0046-2016 | 09-22-2015 | Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 3 vials | Class II | Terminated |
| D-0051-2016 | 09-22-2015 | P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0045-2016 | 09-22-2015 | Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 2 bottles | Class II | Terminated |
| D-0013-2016 | 09-22-2015 | Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX 77043, UPC: 1 88436 00017 4. | Cross Contamination With Other Products: Potential cross-contamination of cephalosporin. | Midway Importing, Inc / 164,332 boxes | Class II | Terminated |
| D-0040-2016 | 09-22-2015 | Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0042-2016 | 09-22-2015 | P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 4 vials | Class II | Terminated |
| D-0048-2016 | 09-22-2015 | P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0052-2016 | 09-22-2015 | P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0041-2016 | 09-22-2015 | P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 4 vials | Class II | Terminated |
| D-0049-2016 | 09-22-2015 | P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0050-2016 | 09-22-2015 | P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0043-2016 | 09-22-2015 | Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0643-2016 | 09-18-2015 | Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 7 Bags | Class II | Terminated |
| D-0640-2016 | 09-18-2015 | Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 9 Bags | Class II | Terminated |
| D-0619-2016 | 09-18-2015 | POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 7 Bags, b) 2 Bags | Class II | Terminated |
| D-0629-2016 | 09-18-2015 | CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 21 Bags, b) 26 Bags c) 3 Bags | Class II | Terminated |
| D-0639-2016 | 09-18-2015 | CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 6 Bags | Class II | Terminated |
| D-0623-2016 | 09-18-2015 | VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 12 Bags, b) 36 Bags, c) 8 Bags, d) 65 Bags, e) 18 Bags, f) 36 Bags g) 21 Bags, h) 7 Bags, i) 3 Bags, j) 3 Bags, k) 2 Bags, l) 6 Bags, m) 3 Bags | Class II | Terminated |
| D-0626-2016 | 09-18-2015 | GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 22 Bags, b) 3 Bags | Class II | Terminated |
| D-0644-2016 | 09-18-2015 | MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 10 Bags | Class II | Terminated |
| D-0633-2016 | 09-18-2015 | FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 7 Bags | Class II | Terminated |
| D-0630-2016 | 09-18-2015 | ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags | Class II | Terminated |
| D-0641-2016 | 09-18-2015 | GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 11 bags, b) 9 Bags, c) 3 Bags | Class II | Terminated |
| D-0632-2016 | 09-18-2015 | PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a)1 Bag, b) 4 Bags | Class II | Terminated |
| D-0628-2016 | 09-18-2015 | Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 3 Bags, b) 60 Bags | Class II | Terminated |
| D-0616-2016 | 09-18-2015 | Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 7, b) 4, c) 8, d) 8, e) 3, f) 4, g) 4, h) 3, i) 4, j) 4, k) 3, l) 3, m) 9, n) 6, o) 3 Bags | Class II | Terminated |
| D-0635-2016 | 09-18-2015 | Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 28 Bags | Class II | Terminated |
| D-0627-2016 | 09-18-2015 | ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 7 Syringes | Class II | Terminated |
| D-0612-2016 | 09-18-2015 | CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 7 Syr, b) 11 Syr, c) 5 Syr, d) 8 Syr, e) 6 Syr, f) 9 Syr, g) 4 Syr, h) 7 Bags, i) 7 Bags, j) 6 Syr, k) 3 Bags l) 4 Syr | Class II | Terminated |
| D-0618-2016 | 09-18-2015 | INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags, f) 7 Bags | Class II | Terminated |
| D-0638-2016 | 09-18-2015 | AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 12 Bags | Class II | Terminated |
| D-0617-2016 | 09-18-2015 | SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 7 Bags | Class II | Terminated |
| D-0611-2016 | 09-18-2015 | MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 159 Bags b) 33 Bags | Class II | Terminated |
| D-0624-2016 | 09-18-2015 | ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 77 Bags | Class II | Terminated |
| D-0622-2016 | 09-18-2015 | DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 7 Bags, b) 4 Bags | Class II | Terminated |
| D-0636-2016 | 09-18-2015 | Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 4 Bags b) 3 Bags c) 6 Bags | Class II | Terminated |
| D-0620-2016 | 09-18-2015 | Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 1 Bag b) 7 Bags c) 8 Bags | Class II | Terminated |
| D-0634-2016 | 09-18-2015 | Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 9 Bags | Class II | Terminated |
| D-0642-2016 | 09-18-2015 | Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 1 Bag | Class II | Terminated |
| D-0631-2016 | 09-18-2015 | MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 5 Bags, b) 4 Bags | Class II | Terminated |
| D-0637-2016 | 09-18-2015 | Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 7 Bags | Class II | Terminated |
| D-0625-2016 | 09-18-2015 | HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag | Class II | Terminated |
| D-0615-2016 | 09-18-2015 | CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags | Class II | Terminated |
| D-0613-2016 | 09-18-2015 | SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags | Class II | Terminated |
| D-0614-2016 | 09-18-2015 | Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 7, b) 7, c) 6, d) 7, e) 4, f) 13, g) 2, h) 4, i) 7, j) 5, k) 10, l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags | Class II | Terminated |
| D-0621-2016 | 09-18-2015 | CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / a) 8 Bags, b) 70 Bags c) 4 Bags | Class II | Terminated |
| D-0018-2016 | 09-17-2015 | WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31074201566 | Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section | The Mentholatum Co. / 80,208 pouches | Class II | Terminated |
| D-0783-2016 | 09-16-2015 | UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, | CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. | Praxair Inc. / 382 cylinders | Class III | Terminated |
| D-0782-2016 | 09-16-2015 | UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006. | CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. | Praxair Inc. / 127 cylinders | Class III | Terminated |
| D-0281-2016 | 09-12-2015 | Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 2,524 vials | Class II | Terminated |
| D-0248-2016 | 09-12-2015 | Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 4,333 vials | Class II | Terminated |
| D-0256-2016 | 09-12-2015 | Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 531 syringes | Class II | Terminated |
| D-0275-2016 | 09-12-2015 | Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 11 vials | Class II | Terminated |
| D-0240-2016 | 09-12-2015 | Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 100 vials | Class II | Terminated |
| D-0244-2016 | 09-12-2015 | Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 135 bottles | Class II | Terminated |
| D-0289-2016 | 09-12-2015 | Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 1,833 bottles | Class II | Terminated |
| D-0260-2016 | 09-12-2015 | L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 1,706 vials | Class II | Terminated |
| D-0247-2016 | 09-12-2015 | Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 2,984 bottles | Class II | Terminated |
| D-0257-2016 | 09-12-2015 | Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 105 syringes | Class II | Terminated |
| D-0280-2016 | 09-12-2015 | Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 1,590 syringes | Class II | Terminated |
| D-0278-2016 | 09-12-2015 | Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 2 bottles | Class II | Terminated |
| D-0274-2016 | 09-12-2015 | Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03. | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 862 bottles | Class II | Terminated |
| D-0287-2016 | 09-12-2015 | Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 33,778 vials | Class II | Terminated |
| D-0255-2016 | 09-12-2015 | Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 5,118 syringes | Class II | Terminated |
| D-0285-2016 | 09-12-2015 | Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 980 vials | Class II | Terminated |
| D-0253-2016 | 09-12-2015 | Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 14,325 syringes | Class II | Terminated |
| D-0293-2016 | 09-12-2015 | Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 2 dropper bottles | Class II | Terminated |
| D-0249-2016 | 09-12-2015 | Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 854 vials | Class II | Terminated |
| D-0270-2016 | 09-12-2015 | Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 5,919 vials | Class II | Terminated |
| D-0243-2016 | 09-12-2015 | Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 589 vials. | Class II | Terminated |
| D-0277-2016 | 09-12-2015 | Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03 | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc / 3,860 dropper bottles | Class II | Terminated |
