Archive
745 recalls were announced in November 2015.
Of the 745 recalls this month scored against our rubric, 3% are Critical, 53% are Severe.
Which agencies issued them
Mack Trucks is recalling 2010-2016 Granite 4X2 trucks because a brake imbalance may cause rear brakes to overheat, increasing the risk of tire blowouts or wheel-end fires.
Newmar is recalling specific 2014-2015 motorhomes because cargo door lock actuators may overheat and melt, increasing the risk of a fire.
Yamaha is recalling 2,921 model year 2015 YZF-R1 motorcycles because transmission gears may fail, potentially causing the transmission to lock up and increasing the risk of a crash.
Forest River is recalling 2014-2016 Legacy motorhomes because the shoulder belt may rest too low, increasing injury risk in a crash.
Terex Environmental is recalling 2007-2015 wood chippers because safety decals may detach, increasing injury risk.
Mama Lina's Inc. is recalling approximately 1,754 pounds of beef and chicken empanada products produced without federal inspection. No adverse reactions have been reported.
Custom Produce Sales is recalling Fat Boy cucumbers due to potential Salmonella contamination. The product was repacked and distributed under a different brand name.
Dole Fresh Vegetables is recalling specific lots of Dole All Natural Spinach after random sampling by the Michigan Department of Agriculture found Salmonella in one bag.
Blue Square Market, Inc. is recalling LiDa DAIDAIHUA capsules nationwide because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA or ANDA.
Triple B Corporation is recalling sliced cucumbers sold to retail delis in Alaska due to potential Salmonella contamination.
Blue Square Market, Inc. is recalling KABOOM action strips because they contain undeclared sulfoaildenafil and were marketed without an approved NDA or ANDA.
Tropical Produce Specialist Corp is recalling 65 boxes of Florida avocados because they tested positive for Salmonella. The product was shipped to two retail locations in Florida.
Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.
US Compounding Inc is recalling 2,984 bottles of compounded Dapiprazole ophthalmic vials nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 304 vials of Magnesium Sulfate Injection because the product lacks assurance of sterility. The affected vials were distributed nationwide and internationally.
US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL) nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.
US Compounding Inc is recalling 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.
Essential Wellness Pharma is recalling QUAD MIX Injection vials because poor sterile production practices may have compromised the sterility of the finished drugs.
Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.
Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.
US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 injection due to deficient practices that may impact sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 25 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised sterility assurance.
US Compounding Inc is recalling MIC Combo multi-dose vials because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5% eye drops nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 160 vials of Magnesium Sulfate Injectable because the company cannot assure the sterility of the product.
Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise sterility assurance.
US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
US Compounding Inc is recalling 1,706 vials of L-Cysteine PF due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling Sermorelin 1000 mcg/mL / LIDO 0.2% Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
FDA is recalling HCG 2000 Units/mL Injection vials from Essential Wellness Pharmacy due to poor sterile production practices.
Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.
Solutions Rx Pharmacy is recalling compounded budesonide nasal rinse capsules due to possible penicillin cross-contamination in the bulk powder.
US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised sterility assurance.
Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.
ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.
Essential Wellness Pharma is recalling BIMIX INJ 30 mg-1 mg/mL Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
US Compounding Inc is recalling 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling Betamethasone SP vials nationwide because deficient practices may have impacted sterility assurance.
Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of sterility assurance.
Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.
Front Row Produce LLC is recalling raw cucumbers in Missouri due to potential Salmonella contamination.
A & S Food Trading Inc. is recalling Hua Zhi Ying Gourd Candy because it contains undeclared sulfites and FD&C Blue #1.
Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.
US Compounding Inc is recalling 1,590 syringes of Succinylcholine Chloride because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling Phenylephrine PF Sterile Solution (2.5%) because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 103 vials of a compounded injection due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection due to poor sterile production practices that compromise sterility assurance.
US Compounding Inc is recalling 7,852 vials of HCG/B12 injection nationwide because deficient practices may have impacted sterility assurance.
US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 467 vials of L-Glutathione Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 96 vials of Bi-Mix sterile preparations nationwide due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.
US Compounding Inc is recalling 22,627 vials of Methylprednisolone PF (80 mg/mL) because deficient practices may have impacted sterility assurance.
Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised sterility assurance.
FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.
Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.
Kar Nut Products Company is recalling 208,008 bags of Kar's Sweet n' Salty Mix due to the possibility of very small pieces of glass in the product.
US Compounding Inc is recalling 82 vials of Alprostadil (PGE-1) nationwide due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling 1,062 vials of HCG (Lyophilized) Injectable because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
US Compounding Inc is recalling 711 fentanyl syringes nationwide because deficient practices may have impacted sterility assurance.
Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.
US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling EDTA Disodium Injectable vials because the company cannot ensure the product is sterile.
Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling HCG 5000 Units/mL injection vials because poor production practices raised concerns about the sterility of the compounded drugs.
Essential Wellness Pharma is recalling MIC Injection vials because poor production practices may have compromised the sterility of the finished drugs.
Downing Labs, LLC is recalling 178 vials of Folic Acid Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed in the US and 17 other countries.
Downing Labs, LLC is recalling 34 vials of Testosterone Cypionate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling TRIMIX #2 Injection vials because poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.
US Compounding Inc is recalling 105 syringes of Hyaluronic Acid/Lidocaine due to deficient practices that may impact sterility assurance.
US Compounding Inc is recalling 11,363 vials of Methylprednisolone/Lidocaine due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromise sterility assurance.
US Compounding Inc is recalling 1,386 vials of Testosterone EO-Pro-Cyp 220 due to deficient practices that may impact sterility assurance.
S. Martinelli & Co is recalling Martinelli's Sparkling Northwest Blend Cider due to the potential for glass fragments in 8.4 oz bottles.
US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1% for intracameral injection due to deficient practices that may impact sterility assurance.
Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment because poor production practices may have compromised sterility.
US Compounding Inc is recalling 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.
Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.
US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate) nationwide because deficient practices may have impacted sterility assurance.
Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromised sterility assurance.
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.
Chrysler is recalling 2013-2014 Dodge Dart vehicles because engine oil may seep into the brake booster, potentially reducing brake assist and increasing stopping distance.
Chrysler is recalling 2015 Ram ProMaster vans because an ignition switch defect may cause the vehicle to stall or disable safety systems like airbags and anti-lock brakes.
Downing Labs, LLC is recalling 98 vials of B12 Injection 12.5/12.5MG due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.
Del Monte is recalling 544 units of Fresco Fresh Banana Strawberry Yogurt Parfait because the product may contain undeclared almonds.
Vaughan Foods is recalling Timeless Garden Salad Kits due to a potential Salmonella contamination risk. The product was distributed in six states.
Kronos Foods is recalling a 4-pound Sample Assortment of baked goods due to the potential for metal fragments. The recall covers 2 cases distributed to specific US states and one Canadian consignee.
US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic drops due to deficient practices that may impact sterility assurance.
Kar Nut Products Company is recalling Golden Flake Trail Mix because the product may contain very small pieces of glass.
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