FDA recalls, September 2019: 154 published

63 different companies appear this month.

Risk classification: Class I: 47 · Class II: 100 · Class III: 7

Same month, other agencies:CPSC 18 recallsFSIS 5 recallsNHTSA 50 recalls

Recalls this month

DateProduct
September 25, 2019Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: …D-1862-2019Torrent Pharma Inc.
September 25, 2019Lantana Black Bean Hummus 2 pack of 10 oz. and 10 oz. UPC 10855432004136 and 208968630017…F-2173-2019Pita Pal Foods LP
September 18, 2019Bubbies Mochi Ice Cream -Chocolate Vanilla Item Code CS812002, UPC Code 20213-4, UPC GTIN…F-2129-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019FungusAmongUs Shiitake Organic Mushrooms are dried mushrooms. Packaged in a clear celloph…F-2151-2019Seattle Gourmet Foods Inc.
September 18, 2019LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Pr…Z-2538-2019Smith & Nephew, Inc.
September 18, 2019Plastic Bottles labeled with: "Ancient Youth Secret - Since 500 B.C., DR. NARAM'S RASAYAN…F-2144-2019Jivan Shakti Inc.
September 18, 2019Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: …D-1851-2019Macleods Pharma Usa Inc
September 18, 2019Stonyfield Kids Strawberry Beet Berry Tubes, 8 count-2oz each; 453g/package; Keep Refrige…F-2152-2019Stonyfield Farm
September 18, 2019Bubbies Mochi Ice Cream -lychee Item Code CS800001, UPC Code 20033-8, UPC GTIN 1078732520…F-2132-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362…D-1847-2019American Health Packaging
September 18, 2019Bubbies Mochi Ice Cream -Pistachio Item Code CS800054, UPC Code 20113-7, UPC GTIN 1078732…F-2135-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx …Z-2488-2019Philips North America, LLC
September 18, 2019Bubbies Mochi Ice Cream -Chocolate Mint Item Code CS812083, UPC Code 20103-8, UPC GTIN 10…F-2128-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Bubbies Cookie Dough Ice Cream Bites -Sugar Cookie Item Code CDR00004, UPC Code 50014-8, …F-2124-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Bubbies Mochi Ice Cream -Passion Fruit Item Code CS800119, UPC Code 20093-2, UPC GTIN 107…F-2134-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019QQ Fish brand CRAB FLAVOURED SEAFOOD BALL; Net weight 200g/7ozF-0005-2020Great One Trading Inc.
September 18, 201910% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, droppe…D-1854-2019Compounded Solutions in Pharmacy
September 18, 2019XP-XP Tibial Tray - Interlok 79 mm Item # 195758Z-2519-2019Zimmer Biomet, Inc.
September 18, 2019Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton.F-2153-2019Abbott Nutrition, Division of Abbott Laboratories
September 18, 2019Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (…F-2147-2019Tri-Union Frozen Products, Inc.
September 18, 2019Bubbies Mochi Ice Cream Premium Variety Pack (Strawberry, Green Tea, Mango) Item Code CS…F-2140-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.Z-2493-2019Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
September 18, 2019TAINY VOSTOKA ASSORTED DRIED FRUITS - QUINCE packaged in 500gram (17.65oz), clear plasti…F-2156-2019Krasnyi Oktyabr Inc. USA
September 18, 2019Bubbies Mochi Ice Cream -Mango Item Code CS800037, UPC Code 20063-5, UPC GTIN 10787325200…F-2133-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Martha White Gluten Free Sweet Yellow Cornbread & Muffin Mix packaged in a 7oz. pouch. 12…F-2121-2019Hometown Food Company
September 18, 2019Bubbies Mochi Ice Cream -Blood Orange Item Code CS800490, UPC Code 20085-7, UPC GTIN 1078…F-2125-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Bubbies Mochi Ice Cream -Chocolate Coconut Item Code CS812067, UPC Code 20203-5, UPC GTIN…F-2126-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable P…Z-2456-2019Allergan PLC
September 18, 2019Trader Joes - Vanilla Item Code 64500, UPC Code 00645003. Product is packed in oriented p…F-2142-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL B…Z-2465-2019Allergan PLC
September 18, 2019QQ Fish brand CUTTLEFISH FLAVOURED SEAFOOD BALL; Net weight 200g/7ozF-0007-2020Great One Trading Inc.
September 18, 2019Ground Cinnamon 4oz plastic container 24 containers per wholesale caseF-2145-2019Kashat Wholesale, Inc.
September 18, 2019Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, F…D-1879-2019Plastikon Healthcare LLC
September 18, 2019XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291Z-2515-2019Zimmer Biomet, Inc.
September 18, 2019Vanguard XP Tibial Tray 63 mm Item # 195245Z-2528-2019Zimmer Biomet, Inc.
September 18, 2019Bubbies Mochi Ice Cream -Green Tea Item Code CS800056, UPC Code 20023-9, UPC GTIN 1078732…F-2130-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, …Z-2313-2019Teleflex Medical
September 18, 2019Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharm…D-1848-2019Mylan Pharmaceuticals Inc.
September 18, 2019Sea Cuisine Citrus Herb Rubbed Salmon. Two Atlantic salmon fillets with lemon, herb, sea …F-2252-2019High Liner Foods Inc.
September 18, 2019QQ Fish brand Tofu Style Fried Fish Cake, 200gF-0004-2020Great One Trading Inc.
September 18, 2019Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx…D-1849-2019Pacifico National, Inc. dba AmEx Pharmacy
September 18, 2019Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF …Z-2316-2019Teleflex Medical
September 18, 2019ROTEM ex-tem Canada Part No: 503-05-CAZ-2486-2019Instrumentation Laboratory Co.
September 18, 2019Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., L…D-1852-2019Pfizer Inc.
September 18, 2019Bubbies Mochi Ice Cream -Chocolate Espresso Item Code CS812079, UPC Code 20053-6, UPC GTI…F-2127-2019Bubbies Homemade Ice Cream and Desserts, Inc.
September 18, 2019XP-XP Tibial Tray - Interlok 65 mm Item # 195752Z-2525-2019Zimmer Biomet, Inc.
September 18, 2019XP-XP Tibial Tray - Interlok 59 mm Item # 195750Z-2527-2019Zimmer Biomet, Inc.
September 18, 2019YoCrunch VANILLA LOWFAT YOGURT WITH SNICKERS PIECES 4 - 4 oz (113g) - 16 oz (453g) 6 pac…F-2246-2019Danone Waters of America, Inc
September 18, 2019Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for …Z-2451-2019Allergan PLC
September 18, 2019ROTEM ex-tem Rest of the world part No: 503-05 (ROW)Z-2487-2019Instrumentation Laboratory Co.

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