FDA recalls, November 2015: 220 published

68 different companies appear this month.

Risk classification: Class I: 25 · Class II: 192 · Class III: 3

Same month, other agencies:CPSC 26 recallsFSIS 10 recallsNHTSA 88 recalls

Recalls this month

DateProduct
November 25, 2015Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx o…D-0289-2016US Compounding Inc
November 25, 2015Ocean's Halo, The Seaweed Chip. Korean BBQ Flavor; 2.5 oz. bag Organic and Gluten Free …F-0264-2016New Frontier Foods/Ocean's Halo
November 25, 2015HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), E…Z-0278-2016Ethicon Endo-Surgery Inc
November 25, 2015Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specif…Z-0285-2016ErgoSafe Products, LLC (DBA) Prism Medical
November 25, 2015Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, S…D-0350-2016Downing Labs, LLC
November 25, 2015TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PH…D-333-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625…D-305-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015Dole All Natural SPINACH; Net Wt. 8 oz. (227 g). Enjoy by 10-15-15, UPC 7143000976 P…F-0193-2016Dole Fresh Vegetables Inc
November 25, 2015Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 4…D-0234-2016Par Pharmaceutical Inc.
November 25, 2015Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection,…D-0285-2016US Compounding Inc
November 25, 2015Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen R…D-0352-2016Downing Labs, LLC
November 25, 2015Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical…D-0277-2016US Compounding Inc
November 25, 2015Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking inst…F-0209-2016National Frozen Foods Corporation--Seattle
November 25, 2015Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the…Z-0277-2016Teleflex Medical
November 25, 2015Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded …D-0276-2016US Compounding Inc
November 25, 2015Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking inst…F-0207-2016National Frozen Foods Corporation--Seattle
November 25, 2015HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Com…D-0254-2016US Compounding Inc
November 25, 2015Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Comp…D-0270-2016US Compounding Inc
November 25, 2015Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL…D-331-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injection Only…D-0263-2016US Compounding Inc
November 25, 2015Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation…Z-0295-2016Fresenius Medical Care Renal Therapies Group, LLC
November 25, 2015MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobala…D-0268-2016US Compounding Inc
November 25, 2015Cucumber, sliced 3/8", product is packaged in a 2 lbs. plastic bag and placed in a cardbo…F-0211-2016Triple B Corporation
November 25, 2015Classic Baklava; Net WT 5.5 lbs (2.43 kg) total weight of five trays bundled together. …F-0232-2016Kronos Foods, Inc.
November 25, 2015CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used i…Z-0290-2016Civco Medical Instruments Co. Inc.
November 25, 2015Sample Assortment Net WT 4 lbs. (1.82 kg) total weight of five trays bundled together.…F-0237-2016Kronos Foods, Inc.
November 25, 2015PROVA, Standard Exhausted Vanilla Seeds, Graines VRAC, Caisses-outres of 50 X Lbs, packag…F-0194-2016Prova Inc
November 25, 2015Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001…D-0364-2016Downing Labs, LLC
November 25, 2015HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. …D-310-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness P…D-322-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peo…D-319-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015Kar's 18 CT. Variety Pack, Box of 9, 3.5 oz. flexible film bags Sweet n' SaltyF-0157-2016Kar Nut Products Company
November 25, 2015Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injecti…D-0284-2016US Compounding Inc
November 25, 2015Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx…D-0293-2016US Compounding Inc
November 25, 2015L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Com…D-0260-2016US Compounding Inc
November 25, 2015Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McE…D-0344-2016Downing Labs, LLC
November 25, 2015Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs…D-0379-2016Downing Labs, LLC
November 25, 2015Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suit…D-0371-2016Downing Labs, LLC
November 25, 2015B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dal…D-0366-2016Downing Labs, LLC
November 25, 2015Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophtha…D-0291-2016US Compounding Inc
November 25, 2015Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL …D-0341-2016Downing Labs, LLC
November 25, 201512-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests…Z-0302-2016Ameditech Inc
November 25, 2015Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking inst…F-0204-2016National Frozen Foods Corporation--Seattle
November 25, 2015Sliced Cucumbers (100/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Sl…F-0216-2016Vaughan Foods
November 25, 201511 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, It…Z-0301-2016Ameditech Inc
November 25, 2015NatureBox Sticks 'n Stones; roasted nuts with sesame sticks 4.5 oz (128 g) pouches - U…F-0219-2016NatureBox, Inc.
November 25, 2015L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, …D-0339-2016Downing Labs, LLC
November 25, 2015Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Well…D-317-2016Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
November 25, 2015Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx onl…D-0253-2016US Compounding Inc
November 25, 2015Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M…D-0354-2016Downing Labs, LLC

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