FDA recalls, August 2012: 776 published

191 different companies appear this month.

Risk classification: Class I: 219 · Class II: 528 · Class III: 29

Same month, other agencies:CPSC 35 recallsNHTSA 66 recalls

Recalls this month

DateProduct
August 22, 2012Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe…Z-2210-2012Maquet Inc.
August 22, 2012LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUT…D-1558-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML …D-1559-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML …D-1563-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS)D-1625-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60…D-1561-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT)D-1565-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE…D-1475-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X1…D-1643-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; …D-1464-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT)D-1605-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIF…D-1447-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in p…Z-2197-2012Edwards Lifesciences, LLC
August 22, 2012HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; H…D-1541-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in …Z-2191-2012Edwards Lifesciences, LLC
August 22, 2012PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML V…D-1599-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 1…D-1580-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)D-1584-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML,…D-1501-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML …D-1622-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in…Z-2192-2012Edwards Lifesciences, LLC
August 22, 2012TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML …D-1633-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)D-1619-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, i…Z-2217-2012DePuy Orthopaedics, Inc.
August 22, 2012NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML …D-1588-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 22, 2012PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML …D-1598-2012Franck's Lab Inc., d.b.a. Franck's Compounding Lab
August 15, 2012i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro d…Z-2170-2012Abbott Point Of Care Inc.
August 15, 2012The Farmers Market brand European Salad Blend, 12 oz bag, UPC: 30034-30125; Product is a…F-1583-2012River Ranch Fresh Foods LLC
August 15, 2012***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation…Z-2158-2012Biomet 3i, LLC
August 15, 2012Onion Rings. Products are labeled in part: "***FP CENTRAL FL. FRESHCUTS***ONIONS FC YE…F-1871-2012FreshPoint Central Florida
August 15, 2012Bean Dip Tray w/Salsa, 52 oz. packaged under Garden Highway label; Fresh Bean Dip with S…F-1894-2012GH Foods CA LLC
August 15, 2012Bean Dip Bowl, 20 oz, packaged under Garden Highway label. Bean Dip snack tray, packaged…F-1892-2012GH Foods CA LLC
August 15, 2012Tartar Sauce sold under the following brand names: 1) Golden Corral Tartar Sauce, 1 gallo…F-1864-2012Ken's Foods, Inc.
August 15, 2012Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), s…Z-2166-2012Smith & Nephew, Inc. Endoscopy Division
August 15, 2012Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neur…D-1442-2012Teva Pharmaceuticals USA, Inc.
August 15, 2012Diced Yellow Onion. 1) Product is labeled in part: "***Onion Yellow Diced***ORB***Ortho…F-1915-2012FreshPoint South Florida
August 15, 2012Onions Yellow Fajita. Products are labeled in part: "***Onions Yellow Slab*** "***FP…F-1873-2012FreshPoint Central Florida
August 15, 2012Yellow Onion. Product is labeled in part: "***Onion Yellow Ring***ORB***Orthodox Rabbin…F-1917-2012FreshPoint South Florida
August 15, 2012Hy Vee brand European Blend, 12 oz bag, UPC: 75450-12049; Product is a salad item; bagge…F-1561-2012River Ranch Fresh Foods LLC
August 15, 2012The finger cots are made out of natural rubber. They are disposable products used to cov…Z-2160-2012Afassco Inc
August 15, 2012Southwestern Snack Bites 5.0 oz, packaged under Delish brand name: Manufactured by GH Fo…F-1885-2012GH Foods CA LLC
August 15, 2012River Ranch brand Iceberg & Romaine 50/50, 4 x 5lb bag, UPC: n/a; Product is a salad item…F-1604-2012River Ranch Fresh Foods LLC
August 15, 2012Conch Salad w/onions. Product is labeled in part: "***KEYS FISHERIES CONCH SALAD***Ingr…F-1930-2012Keys Fisheries, Inc.
August 15, 2012Asian Stir Fry, packaged under the following labels and sizes: Delish, 8.5 oz. Albertso…F-1882-2012GH Foods CA LLC
August 15, 2012Shurfresh brand Cole Slaw, 16 oz bag, UPC: 11161-49088; Product is a salad item; bagged …F-1573-2012River Ranch Fresh Foods LLC
August 15, 2012Whole peeled Yellow onions, 30 lbs, UPC 02060042553, "Western Onion" label; Whole peeled…F-1852-2012Gills Onions, LLC
August 15, 2012The Farmers Market brand Garden Salad, 6 oz, 12 oz, 24 oz bags, UPCs: 30034-30012, 3003…F-1585-2012River Ranch Fresh Foods LLC
August 15, 2012Yellow Onion. Product is labeled in part: "***Onion Yellow Julienne***ORB***Orthodox Ra…F-1916-2012FreshPoint South Florida
August 15, 2012River Ranch brand Heritage Blend, 16 oz bag, UPC: n/a; Product is a salad item; bagged in…F-1558-2012River Ranch Fresh Foods LLC
August 15, 2012River Ranch brand Garden with Romaine, 4 x 5 lb bag, UPC: n/a; Product is a salad item; b…F-1601-2012River Ranch Fresh Foods LLC

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