Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

FDA Drug Class II Terminated

Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 5 10 mL vials units
FDA Drug Class II Terminated

Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 30 vials units
FDA Drug Class II Terminated

Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 93 vials units
FDA Drug Class II Terminated

IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 59 vials units
FDA Drug Class II Terminated

Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 341 vials units
FDA Drug Class II Terminated

Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 158 10 ml vials units
FDA Drug Class II Terminated

Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 1 vial units
FDA Drug Class II Terminated

Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 139 vials units
FDA Drug Class II Terminated

HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 819 vials units
FDA Drug Class II Terminated

HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 654 vials units
FDA Drug Class II Terminated

Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 8 10ml vials units
FDA Drug Class II Terminated

Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

December 17, 2018 Promise Pharmacy LLC 2057 6 ml bottles units
FDA Drug Class II Terminated

Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 296 vials units
FDA Drug Class II Terminated

Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98

December 17, 2018 Duren Health Mart Pharmacy 300 grams units
FDA Drug Class II Terminated

Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 64 vials units
FDA Drug Class II Terminated

Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 25 vials units
FDA Drug Class II Terminated

Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 43 vials units
FDA Drug Class II Terminated

Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07

December 17, 2018 Duren Health Mart Pharmacy 2700 cc units
FDA Drug Class II Terminated

Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 43 3 mL bottles units
FDA Drug Class II Terminated

Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy C

December 17, 2018 Promise Pharmacy LLC 5 vials units
FDA Drug Class II Terminated

Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 252 vials units
FDA Drug Class II Terminated

Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mc

December 17, 2018 Promise Pharmacy LLC 158 10 ml vials units
FDA Drug Class II Terminated

IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 59 vials units
FDA Drug Class II Terminated

Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 7 10 ml vials units
FDA Drug Class II Terminated

Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 196 50 ml vials units
FDA Drug Class II Terminated

Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 55 3 ml bottles units
FDA Drug Class II Terminated

Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03

December 17, 2018 Duren Health Mart Pharmacy 876 cc units
FDA Drug Class II Terminated

HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 2595 vials units
FDA Drug Class II Terminated

Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 11 10ml vials units
FDA Drug Class II Terminated

Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 704 vials units
FDA Drug Class II Terminated

Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 15 10ml vials units
FDA Drug Class II Terminated

Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01

December 17, 2018 Duren Health Mart Pharmacy 1306 capsules units
FDA Drug Class II Terminated

Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 255 vials units
FDA Drug Class II Terminated

Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

December 17, 2018 Promise Pharmacy LLC 210 5 ml vials units
NHTSA Ongoing

Passenger Frontal Air Bag Inflator May Explode

December 17, 2018 Toyota Motor Engineering & Manufacturing 168,993 units
NHTSA Ongoing

Brake Master Cylinder Seal may be Damaged

December 17, 2018 Toyota Motor Engineering & Manufacturing 44,121 units
NHTSA Ongoing

Sensor Wire may Break Deactivating Air Bags

December 17, 2018 Toyota Motor Engineering & Manufacturing 89,740 units
NHTSA Ongoing

Blocked Emergency Exit May Hinder Passenger Exit

December 17, 2018 Gillig LLC 30 units
NHTSA Ongoing

Fuel Hose or Brake Line Fluid Leak

December 17, 2018 BLUE BIRD BODY COMPANY 5,169 units
NHTSA Ongoing

Fuel Hose or Brake Line Fluid Leak

December 17, 2018 BLUE BIRD BODY COMPANY 32 units
FDA Food Class I Terminated

greens & Grains Hummus & Quinoa Tabouleh Wrap with lemon tahini dressing: Perishable: Keep Refrigerated Plastic container with tamper proof hinged lid Use by 12/19/18 Incorrect dressing was use

December 16, 2018 Atherstone Foods Inc dba Glass Onion Catering 114 units units
FDA Food Class I Terminated

Eat Smart Salad Shake Ups - Tropical Lime/Lime Tropicale 5.5 oz. (156 g); US UPC 7 09351-30179 7; 7 09351 30197 1 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434

December 15, 2018 Apio, Inc.
FDA Food Class I Terminated

Eat Smart Salad Shake Ups - Avocado Ranch/Ranch et Avocats: 5.5 oz. (156 g); US UPC: 7 09351-30177 3; Canadian UPC: 7 09351 30195 7; Product of USA Distributed by Apio Inc., Guadalupe, Ca 934

December 15, 2018 Apio, Inc.
FDA Food Class I Terminated

Eat Smart Salad Shake Ups - Raspberry Acai/Framboises ET: 5.5 oz. (156 g); US UPC 7 09351-30178 0; Canadian UPC: 7 09351 30196 4. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434

December 15, 2018 Apio, Inc.
FDA Food Class I Terminated

Eat Smart Salad Shake Ups - Asian Sesame/Sesame Asiatique; 5.5 oz. (156 g); UPC 7 09351-30241 1, 7 09351 30244 2 Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434

December 15, 2018 Apio, Inc.
FDA Food Class I Terminated

Eat Smart Salad Shake Ups - Sweet Kale/Chou Frise Doux: 5.5 oz. (156 g); US UPC 7 09351-30240 4; Canadian UPC: 7 09351 30243 5. Product of USA Distributed by Apio Inc., Guadalupe, Ca 93434

December 15, 2018 Apio, Inc.
FDA Food Class I Terminated

-Washed and Packed Whole Green Lettuce Fillets, item # 80415, are packaged in 10 lbs. cases, foodservice item distributed without label. -Washed and Packed Whole Green Lettuce Fillets, item # 80416

December 14, 2018 Spokane Produce, Inc. Green Lettuce Fillets (16/10 lb. cases and 11/5 lb. cases); Green Lettuce heads (36/6 ct. Bags) units
FDA Food Class I Terminated

Italian Tapenade sandwich is Hoagie sandwich made with pepperoni, salami, capicola, cheese, Tapenade spread and green leaf lettuce. -Italian Tapenade or Italian Hoagie sandwich, 7.7 oz, UPC 88694 7

December 14, 2018 Spokane Produce, Inc. 254 units total units
FDA Food Class I Terminated

Turkey Bacon Cheddar sandwiches were made with Turkey, Bacon, Cheddar Cheese, Green Leaf and Seasoned Mayonnaise. -Turkey Bacon Cheddar, 7.4 oz, UPC 88694 79804, Northwest Cuisine Creations brand.

December 14, 2018 Spokane Produce, Inc. 329 units total units
FDA Food Class I Terminated

Tuscan Ham sandwich is a Hoagie bread made with Ham, Processed Swiss Cheese, green leaf and Tapenade. -Tuscan Ham, 7 oz, UPC 88694 79815, brand Northwest Cuisine Creations brand. -Tuscan Ham, 7 oz

December 14, 2018 Spokane Produce, Inc. 174 units units