FDA recalls, January 2019: 55 published

29 different companies appear this month.

Risk classification: Class I: 16 · Class II: 37 · Class III: 2

Same month, other agencies:CPSC 1 recallsFSIS 8 recallsNHTSA 104 recalls

Recalls this month

DateProduct
January 30, 2019curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syrin…D-0384-2019Bound Tree Medical, LLC
January 30, 2019curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Adm…D-0383-2019Bound Tree Medical, LLC
January 30, 2019Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC …D-0385-2019Bound Tree Medical, LLC
January 30, 2019Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-…D-0386-2019Bound Tree Medical, LLC
January 30, 2019ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia S…Z-0742-2019Draeger Medical, Inc.
January 30, 2019LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distribute…D-0391-2019Sun Pharmaceutical Industries, Inc.
January 23, 2019Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-coun…D-0381-2019Teva Pharmaceuticals USA
January 23, 2019EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bott…D-0378-2019Syntho Pharmaceuticals, Inc.
January 23, 2019U by Kotex¿ Sleek¿, Regular Tampons, 18 CountZ-0748-2019Kimberly-Clark Corporation
January 23, 2019Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Phar…D-0370-2019Aurobindo Pharma USA Inc.
January 23, 2019EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count…D-0377-2019Syntho Pharmaceuticals, Inc.
January 23, 2019U by Kotex¿ Sleek¿, Regular Tampons, 3 CountZ-0751-2019Kimberly-Clark Corporation
January 23, 2019curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe …D-0371-2019Bound Tree Medical, LLC
January 23, 2019PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 4…Z-0747-2019Ethicon, Inc.
January 23, 2019PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Crypt…Z-0732-2019Meridian Bioscience Inc
January 23, 2019Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufacture…D-0364-2019Aurobindo Pharma USA Inc.
January 23, 2019Hiland Chocolate Milk, 1/2 gallon (1.89 L). Hiland Dairy Springfield, MO 65803F-1056-2019Hiland Dairy Foods Company LLC
January 23, 2019LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D…Z-0733-2019Waldemar Link GmbH & Co. KG (Mfg Site)
January 16, 2019Adam Bros. Family Farms Cauliflower; Sold in cases with 9, 12, 16 or 20 count casesF-0765-2019Adam Bros. Farming, Inc.
January 16, 2019Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)10…D-0376-2019Lupin Pharmaceuticals Inc.
January 16, 2019Adam Bros. Family Farms Red Leaf Lettuce 24 heads per carton Adams Bros Family Farms …F-0763-2019Adam Bros. Farming, Inc.
January 16, 2019Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-…D-0356-2019Lupin Pharmaceuticals Inc.
January 16, 2019Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcu…D-0352-2019Heritage Pharmaceuticals, Inc.
January 16, 2019DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mo…Z-0692-2019Agfa-Gevaert, N.V.
January 16, 2019ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version)…Z-0697-2019Swissray Medical AG
January 16, 2019Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-…D-0355-2019Lupin Pharmaceuticals Inc.
January 16, 2019IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablati…Z-0701-2019Boston Scientific Corporation
January 16, 2019Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71…D-0350-2019Glenmark Pharmaceuticals Inc., USA
January 16, 2019Adam Bros. Family Farms Green Leaf Lettuce; 24 heads per caseF-0764-2019Adam Bros. Farming, Inc.
January 16, 2019Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)10…D-0375-2019Lupin Pharmaceuticals Inc.
January 16, 2019Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01)…D-0357-2019Lupin Pharmaceuticals Inc.
January 16, 2019Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized,…D-0372-2019Sun Pharmaceutical Industries, Inc.
January 9, 2019Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: …Z-0690-2019Ultradent Products, Inc.
January 9, 2019MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vialD-0399-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019Lidocaine gel 1%, RX, plastic dropperD-0408-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019Hydroxyprogesterone liquid, 250mg/ml, RX, glass vialD-0396-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019Glutathione liquid, 200mg/ml, RxD-0407-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019HCG liquid, 1000u/ml, RX, glass vial, variousD-0395-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019Methocarbamol liquid 100mg/ml, RX, glass vialD-0400-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019Lidocaine gel 2%, RX, plastic dropperD-0397-2019Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
January 9, 2019StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical…Z-0552-2019Medtronic Navigation, Inc.
January 2, 2019HydroSet XT Injectable HA Bone Cement, REF 897003, STERILEZ-0677-2019Howmedica Osteonics Corp.
January 2, 2019Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats: 5.5 oz. (156 g); US UPC: 7 …F-0819-2019Apio, Inc.
January 2, 2019ABL800 analyzer, model numbers 393-800 and 393-801.Z-0682-2019Radiometer America Inc
January 2, 2019Frozen Unbreaded Egg, 3 Cheese and caramelized onion. Sample Number 18-0115.01. Keep Fr…F-0753-2019Sargento Foods, Inc.
January 2, 2019Frozen Unbreaded Egg, Gouda, caramelized onion. Sample Number 18-0116.01. Keep Frozen a…F-0754-2019Sargento Foods, Inc.
January 2, 2019AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative m…Z-0672-2019Tosoh Bioscience Inc
January 2, 2019Tamy Pop 18 pieces Net Wt. 1 lb. 15.7 oz. packaged in a clear plastic jar, 6 jars per caseF-0760-2019Procesadora de Dulces Tipicos, S.A. de C.V.
January 2, 2019Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5.5 oz. (156 g); US UPC 7 093…F-0820-2019Apio, Inc.
January 2, 2019Alinity i Progesterone Reagent Kit, List Number 08P3620Z-0668-2019Abbott Ireland Diagnostics Division

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