FDA recalls: September 2013
Every food and drug recall report the FDA published in September 2013: 206 reports, 31 of them Class I.
- Recall reports
- 206
- Class I (serious)
- 31
- Food
- 62
- Drugs
- 144
- Sep 25, 2013Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Admi…Drug · Leiter's PharmacyLack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence…Class II
- Sep 25, 2013Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compou…Drug · Leiter's PharmacyLack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence…Class II
- Sep 25, 2013Bevacizumab (Avastin) 2Drug · Leiter's PharmacyLack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing.…Class II
- Sep 25, 2013Lidocaine/Phenylephrine PF 1%/1Drug · Leiter's PharmacyLack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing.…Class II
- Sep 25, 2013IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only,…Drug · Dr. Reddy's Laboratories, Inc.Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.Class II
- Sep 25, 2013Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for…Drug · JCB Labs LLCLack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm…Class II
- Sep 25, 2013Sodium Thiosulfate 25%, 250 mg/mL (12Drug · JCB Labs LLCLack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm…Class II
- Sep 25, 2013Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi…Drug · JCB Labs LLCLack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm…Class II
- Sep 25, 2013Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for O…Drug · JCB Labs LLCLack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm…Class II
- Sep 25, 2013Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite…Drug · JCB Labs LLCLack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm…Class II
- Testosterone Cyp 200 mg/mL, W/Pres
- Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg
- Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
- L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
- Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
- Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
- NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
- NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
- Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, De…
- SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx…
- Bevacizumab 1
- Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684
- Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj
- Hydrocodone Bitartrate and Acetaminophen Tablets, 7
- Frozen Hot Smoked Vacuum Packed Salmon
- Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc
- Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17…
- Meyer Lemon Braising Base, 1lb
- 40-Clove Garlic Chicken Braising Base, 24
- Professor Zim Zam's Extraordinary Sweets
- Professor Zim Zam's Extraordinary Sweets
- Professor Zim Zam's Extraordinary Sweets
- Tagine Sauce, 16 fl
- Artichoke Pecorino Sauce, 16 fl
- Olde Cape Cod Chipotle Ranch dressing, 16 oz
- "***SUPERPAN***Tu Pan Natural***"
- "***SUPERBUDIN"
- Liquid Yeast Cream, Bulk, in tanker truck quantities, refrigerated 33F-45F
- Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12
- Round Fresh Tomatoes sold in bulk boxes, 20 lbs
- Coffee Cake: queso/guava (cheese/guava)
- Coffee Cake: queso crema (creme cheese)
- Coffee Cake: queso/fresa (cheese/strawberry)
- Coffee Cake: queso/manzana (cheese/apple)
- Bean & Cheese Burrito Filling, 10 lb bags Labeled in part "13210 B 1 77220 13:38 KEEP F…
- Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewab…
- Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewabl…
- Benefiber, Fiber Supplement, 72ct and 114 caplet bottles
- Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets
- Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles
- Frozen, 4/3 lb unlabeled bags contained in a master carton box labeled in part: "Porti…
- SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND…
- SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AN…
- TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJ…
- TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration,…
- TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ…
- TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all co…
- TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE…
- TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SO…
- TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE,…
- VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJE…
- VITAMIN D 50,000 I
- Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STE…
- ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX…
- ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND…
- B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STER…
- BUPRENORPHINE 0
- CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,…
- CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY,…
- MANGANESE SULFATE 0
- Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds,…
- Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compound…
- Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Ph…
- Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, Univ…
- PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 85…
- PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 8…
- Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple…
- Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Mult…
- Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Co…
- Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph…
- EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, R…
- Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627
- Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY,…
- Methyl B12 1 mg/mL P
- NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY,…
- RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARM…
- Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627
- K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbona…
- EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM…
- Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL…
- ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, S…
- ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO…
- B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, R…
- B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ON…
- ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STER…
- ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONL…
- B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STE…
- B12/E2/E3/PROG/TEST 1/3
- BI-MIX PHENTOLAMINE/PAPAVERINE 0
- BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, R…
- CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY…
- CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE…
- COPPER 0
- CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,…
- DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AN…
- DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, S…
- DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE,…
- DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, S…
- DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX…
- DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTR…
- EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONL…
- ESTRADIOL CYP/PROG/TEST CYP 0
- ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND…
- ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRA…
- ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE…
- FREAMINE III ALT
- FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERI…
- GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE…
- GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY,…
- GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ US…
- GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20…
- GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE,…
- GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY,…
- H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, al…
- HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER…
- HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and…
- HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO an…
- HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO…
- KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ US…
- L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, ST…
- LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/M…
- LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ON…
- LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ…
- MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ…
- MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STE…
- METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML,…
- METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR IN…
- MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0
- MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE…
- MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX…
- NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, S…
- NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVEN…
- NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRA…
- OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ON…
- PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE,…
- PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ON…
- POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONL…
- PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STE…
- PROG/TEST CYP 15/7
- PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, S…
- PUMICE/LIDOCAINE HCL 1
- PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE O…
- QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND S…
- SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STER…
- SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,…
- SODIUM BICARBONATE PF 8
- SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ…
- Stonyfield Organic O Soy Yogurt Strawberry , 6 oz
- First Street Coffee Cake Muffins (S 45398) 4 count 14 oz
- Clinical LIVE Dietary Supplement Immune Support 694
- New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc
- New Sun Immune 101, Dietary Supplement 360 Capsule bottles and 100 capsule bottles, New…
- CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc
- SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4,…
- Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4,…
- 1) terrafina Natural Roasted Salted Pistachios
- 1) terrafina Natural Roasted Unsalted Pistachios
- Butter (salted)
- Tortillas Lupita Flour Tortillas
- Chocolate covered raisinsin 4 oz flexible bags labeled in part "***Pennsylvania Dutch C…
- Baltic Sprats in Spicy Brine Net Wt
- Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16
- THRIVE 6 Grain Pancake Mix
- Potter's Crackers, Classic White
- Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free
- H-E-B Jumbo Butterfly Shrimp-10
- Dove Chocolate Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blue…
- El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil
- Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific…
- Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)
- Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
- ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Sarato…
- buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bot…
- Avastin, (0
- ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Ru…
- Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single…
- Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC
- 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc.…
- Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Blo…
- Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactur…
- Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only…
- Ketorolac Tromethamine Inj
- Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop V…
- Tres Leches cake sold under the following brand names: 1) "****Tres Leches***Postres D'…
- Morbier Les 3 Comtois, 11 lb
- Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358
- Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9
- See's Candies, Van Doren Dark Chocolate Blueberries
- Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE
- Sour Cherry Crostata, 1 pie Net
- Blueberry Crostata, 1 pie Net
- Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc
- Nature's Earthly Choice Organic Quinoa Distributed by Nature's Earthly Choice Eagle,…
- Garbanzo Iced Lemon Grass Ginger Tea 3 oz foil portion packs
- Long Life Premium Organic Green Tea with Lemongrass, packages of 18 tea bags, (27 grams/
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