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 July 25, 2025 and include a total of 16975 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0042-201609-22-2015P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 4 vialsClass IITerminated
D-0048-201609-22-2015P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0041-201609-22-2015P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 4 vialsClass IITerminated
D-0049-201609-22-2015P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0052-201609-22-2015P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0013-201609-22-2015Sedalmex (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 boxesClass IITerminated
D-0040-201609-22-2015Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0045-201609-22-2015Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 2 bottlesClass IITerminated
D-0044-201609-22-2015Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0043-201609-22-2015Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0050-201609-22-2015P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0047-201609-22-2015Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 2 vialClass IITerminated
D-0051-201609-22-2015P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 1 vialClass IITerminated
D-0046-201609-22-2015Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919Lack of assurance of sterilityBedford Pharmacy / 3 vialsClass IITerminated
D-0622-201609-18-2015DOBUTAMINE 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 BagsClass IITerminated
D-0611-201609-18-2015MEROPENEM 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 BagsClass IITerminated
D-0627-201609-18-2015ASCORBIC 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 SyringesClass IITerminated
D-0624-201609-18-2015ONDANSETRON 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 BagsClass IITerminated
D-0638-201609-18-2015AZACTAM (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 BagsClass IITerminated
D-0617-201609-18-2015SOLUMEDROL (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 BagsClass IITerminated
D-0634-201609-18-2015Ampicillin/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 BagsClass IITerminated
D-0636-201609-18-2015Lactated 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 BagsClass IITerminated
D-0642-201609-18-2015Tobramycin 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 BagClass IITerminated
D-0618-201609-18-2015INTRALIPID (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 BagsClass IITerminated
D-0612-201609-18-2015CUBICIN (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 SyrClass IITerminated
D-0620-201609-18-2015Dextrose-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 BagsClass IITerminated
D-0619-201609-18-2015POTASSIUM 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 BagsClass IITerminated
D-0629-201609-18-2015CEFEPIME, 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 BagsClass IITerminated
D-0640-201609-18-2015Solu-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 BagsClass IITerminated
D-0643-201609-18-2015Dextrose-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 BagsClass IITerminated
D-0615-201609-18-2015CEFAZOLIN, 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 BagsClass IITerminated
D-0625-201609-18-2015HYDROMORPHONE 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 BagClass IITerminated
D-0613-201609-18-2015SOD 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 BagsClass IITerminated
D-0621-201609-18-2015CEFTRIAXONE 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 BagsClass IITerminated
D-0614-201609-18-2015Parenteral 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 BagsClass IITerminated
D-0626-201609-18-2015GANCICLOVIR 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 BagsClass IITerminated
D-0631-201609-18-2015MORPHINE 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 BagsClass IITerminated
D-0623-201609-18-2015VANCOMYCIN 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 BagsClass IITerminated
D-0637-201609-18-2015Cancidas (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 BagsClass IITerminated
D-0633-201609-18-2015FLUCONAZOLE 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 BagsClass IITerminated
D-0641-201609-18-2015GENTAMICIN, 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 BagsClass IITerminated
D-0632-201609-18-2015PENICILLIN 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 BagsClass IITerminated
D-0635-201609-18-2015Nafcillin 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 BagsClass IITerminated
D-0616-201609-18-2015Milrinone 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 BagsClass IITerminated
D-0628-201609-18-2015Invanz (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 BagsClass IITerminated
D-0644-201609-18-2015MYCAMINE (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 BagsClass IITerminated
D-0630-201609-18-2015ZOSYN (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 BagsClass IITerminated
D-0639-201609-18-2015CLINDAMYCIN 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 BagsClass IITerminated
D-0018-201609-17-2015WellPatch¿ 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 31074201566Labeling: 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" sectionThe Mentholatum Co. / 80,208 pouchesClass IITerminated
D-0783-201609-16-2015UN1002 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 cylindersClass IIITerminated
D-0782-201609-16-2015UN1002 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 cylindersClass IIITerminated
D-0281-201609-12-2015Testosterone 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 62295-2131-07Lack 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 vialsClass IITerminated
D-0275-201609-12-2015Phenylephrine (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 62295-3289-05Lack 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 vialsClass IITerminated
D-0287-201609-12-2015Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01Lack 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 vialsClass IITerminated
D-0255-201609-12-2015Hyaluronic 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 62295-3087-02Lack 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 syringesClass IITerminated
D-0260-201609-12-2015L-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 62295-3239-01Lack 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 vialsClass IITerminated
D-0247-201609-12-2015Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99Lack 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 bottlesClass IITerminated
D-0257-201609-12-2015Hyaluronic 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 62295-3239-01Lack 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 syringesClass IITerminated
D-0280-201609-12-2015Succinylcholine 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 62295-3292-07Lack 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 syringesClass IITerminated
D-0244-201609-12-2015Cyclo/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 62295-3049-03Lack 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 bottlesClass IITerminated
D-0278-201609-12-2015Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653Lack 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 bottlesClass IITerminated
D-0240-201609-12-2015Betamethasone 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 62295-3240-07Lack 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 vialsClass IITerminated
D-0248-201609-12-2015Dex 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 62295-3299-02Lack 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 vialsClass IITerminated
D-0256-201609-12-2015Hyaluronic 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 62295-3249-03Lack 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 syringesClass IITerminated
D-0274-201609-12-2015Phenylephrine 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 bottlesClass IITerminated
D-0289-201609-12-2015Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02Lack 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 bottlesClass IITerminated
D-0270-201609-12-2015Morphine 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 62295-2171-02Lack 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 vialsClass IITerminated
D-0249-201609-12-2015Dex 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 62295-3057-06Lack 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 vialsClass IITerminated
D-0269-201609-12-2015MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.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 / 1,736 vialsClass IITerminated
D-0293-201609-12-2015Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10Lack 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 bottlesClass IITerminated
D-0285-201609-12-2015Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07Lack 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 vialsClass IITerminated
D-0253-201609-12-2015Glycopyrrolate 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 62295-3082-05Lack 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 syringesClass IITerminated
D-0243-201609-12-2015Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07Lack 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 IITerminated
D-0277-201609-12-2015Phenylephrine 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 62295-3272-03Lack 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 bottlesClass IITerminated
D-0283-201609-12-2015Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07Lack 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 / 1,093 vialsClass IITerminated
D-0262-201609-12-2015Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07Lack 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 / 1,421 vialsClass IITerminated
D-0286-201609-12-2015Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06Lack 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 / 13,843 vialsClass IITerminated
D-0245-201609-12-2015Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07Lack 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 / 1,198 bottlesClass IITerminated
D-0276-201609-12-2015Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07Lack 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 / 14,580 vialsClass IITerminated
D-0254-201609-12-2015HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99Lack 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 / 7,852 vialsClass IITerminated
D-0273-201609-12-2015Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01Lack 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 / 542 vialsClass IITerminated
D-0237-201609-12-2015Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.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 / 82 vialsClass IITerminated
D-0252-201609-12-2015Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50Lack 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 / 711 syringesClass IITerminated
D-0290-201609-12-2015Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07Lack 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 / 751 bottlesClass IITerminated
D-0272-201609-12-2015Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02Lack 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 / 8,218 vialsClass IITerminated
D-0261-201609-12-2015Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07Lack 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 / 7,320 syringesClass IITerminated
D-0263-201609-12-2015MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3113-07Lack 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 / 439 vialsClass IITerminated
D-0242-201609-12-2015Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05Lack 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 / 96 vialsClass IITerminated
D-0264-201609-12-2015Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.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 / 265 vialsClass IITerminated
D-0236-201609-12-2015ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.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 dropper bottlesClass IITerminated
D-0266-201609-12-2015MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.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 / 22,627 vialsClass IITerminated
D-0292-201609-12-2015Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06Lack 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 / 55 vialsClass IITerminated
D-0279-201609-12-2015Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653Lack 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 bottleClass IITerminated
D-0282-201609-12-2015Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06Lack 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 / 1,386 vialsClass IITerminated
D-0250-201609-12-2015Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02Lack 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 / 235 vialsClass IITerminated
D-0239-201609-12-2015Betamethasone Combo PF 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 62295-3018-02Lack 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 / 5,514 vialsClass IITerminated
D-0271-201609-12-2015Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05Lack 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 / 15,640 syringesClass IITerminated
D-0265-201609-12-2015MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07Lack 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 / 3,629 vialsClass IITerminated
D-0291-201609-12-2015Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64Lack 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 / 494 syringesClass IITerminated
D-0268-201609-12-2015MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.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 / 1,939 vialsClass IITerminated