FDA recalls, September 2015: 317 published

59 different companies appear this month.

Risk classification: Class I: 62 · Class II: 246 · Class III: 9

Same month, other agencies:CPSC 35 recallsFSIS 8 recallsNHTSA 75 recalls

Recalls this month

DateProduct
September 23, 2015Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Fr…D-1709-2015The Compounding Pharmacy of America
September 23, 2015Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temp…D-1690-2015The Compounding Pharmacy of America
September 23, 2015LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature,…D-1734-2015The Compounding Pharmacy of America
September 23, 2015Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy…D-1720-2015The Compounding Pharmacy of America
September 23, 2015Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of A…D-1547-2015The Compounding Pharmacy of America
September 23, 2015Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TND-1741-2015The Compounding Pharmacy of America
September 23, 2015Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate…D-1623-2015The Compounding Pharmacy of America
September 23, 2015Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Soluti…D-1731-2015The Compounding Pharmacy of America
September 23, 2015Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solutio…D-1675-2015The Compounding Pharmacy of America
September 23, 2015Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Co…D-1550-2015The Compounding Pharmacy of America
September 23, 2015Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The Co…D-1553-2015The Compounding Pharmacy of America
September 16, 2015White Chocolate Coconut Bucket, 819, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic …F-3149-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Blood Orange Sorbet Bucket, 387, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic buck…F-3188-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Roxbury Road Ice Cream Bucket, 362, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic b…F-3129-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Guava Buttermilk Frozen Yogurt Sandwich Case, 507, Jeni's Splendid Ice Creams, LLC, 5oz s…F-3193-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Oregon Fir Ice Cream Bucket, 363, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic buc…F-3119-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Lemon Frozen Yogurt Bucket, 315, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic buck…F-3180-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate …Z-2744-2015Biomet Spine, LLC
September 16, 2015Rum Ball Ice Cream Bucket, 384, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucke…F-3130-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Sun-Popped Corn Bucket, 815, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, …F-3139-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Brown Ice Cream Bucket, 803, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, …F-3097-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Sugar Plum Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, in…F-3223-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Mini Salty Caramel Sandwich, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, i…F-3210-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Goat Cheese w/Red Cherries Ice Cream Bucket, 312, Jeni's Splendid Ice Creams, LLC, 3 gall…F-3109-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Cinderella Pumpkin Ice Cream Bucket , 371, Jeni's Splendid Ice Creams, LLC, 3 gallons, pl…F-3104-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Green Tomato Buttermilk Frozen Yogurt Buckets, Jeni's Splendid Ice Creams, LLC, 3 gallons…F-3176-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Savannah Buttermint Ice Cream Bucket, 388, Jeni's Splendid Ice Creams, LLC, 3 gallons, pl…F-3134-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Mini Chocolate Truffle Sandwich Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, p…F-3206-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Brambleberry Crisp Ice Cream Bucket, 307, Jeni's Splendid Ice Creams, LLC, 3 gallons, pla…F-3096-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Double-Toasted Coconut Ice Cream Bucket, 349, Jeni's Splendid Ice Creams, LLC, 3 gallons,…F-3107-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Sweet Cream w/ Molasses & Peanuts Ice Cream Bucket, 352, Jeni's Splendid Ice Creams, LLC,…F-3142-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Beet + Grapefruit Shrub Sorbet Pint Case, 205, Jeni's Splendid Ice Creams, LLC, pint size…F-3212-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Black Currant Huckleberry, Brioche and Jam Ice Cream Bucket, 313, Jeni's Splendid Ice Cre…F-3092-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Blue Raspberry Ice Bucket, 818, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucke…F-3192-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Cantaloupe & Sun Tea Sorbet Bucket, 360, Jeni's Splendid Ice Creams, LLC, 3 gallons, plas…F-3189-2015Jeni's Splendid Ice Creams LLC
September 16, 2015CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of th…Z-2742-2015Terumo Cardiovascular Systems Corporation
September 16, 2015Eclair Ice Cream Bucket, 810, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket,…F-3108-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Batdorf Coffee w/ Cream & Sugar Bucket, 383, Jeni's Splendid Ice Creams, LLC, 3 gallons, …F-3163-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Banana French Toast Bucket, 354, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic buck…F-3158-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Rainbow Frozen Yogurt Bucket, 344, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bu…F-3183-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Mini Dark Chocolate Hazelnut Sandwich, Jeni's Splendid Ice Creams, LLC, mini Sandwich, pa…F-3207-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Pineapple Cake Frozen Yogurt Bucket, 358, Jeni's Splendid Ice Creams, LLC, 3 gallons, pla…F-3182-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Dark Chocolate Hazelnut Macaroon Sandwich Case, 502, Jeni's Splendid Ice Creams, LLC, 6.2…F-3196-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Hot Toddy Sorbet Pint Case, 202, Jeni's Splendid Ice Creams, LLC, pint size, plastic cont…F-3215-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceut…D-1422-2015Mutual Pharmaceutical Company, Inc.
September 16, 2015IQF Red Tart Cherries, 30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed …F-3089-2015Coloma Frozen Foods, Inc.
September 16, 2015Red Tart Pitted Cherries, Straight Packed (No Sugar), 5 lbs. bulk pails, 30 lbs, in bulk…F-3091-2015Coloma Frozen Foods, Inc.
September 16, 2015Gooey Buttercake Ice Cream Bucket, 820, Jeni's Splendid Ice Creams, LLC, 3 gallons, plast…F-3110-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Pistachio & Honey Ice Cream Bucket, 319, Jeni's Splendid Ice Creams, LLC, 3 gallons, plas…F-3122-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Seven Layer Bar Ice Cream Bucket, 393, Jeni's Splendid Ice Creams, LLC, 3 gallons, plasti…F-3135-2015Jeni's Splendid Ice Creams LLC

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