November 2015 recalls

745 recalls were announced in November 2015.

What the numbers show

Critical: 22
Severe: 397
High: 235
Moderate: 76
Low: 15

Of the 745 recalls this month scored against our rubric, 3% are Critical, 53% are Severe.

Which agencies issued them

101–200 of 745

SevereFDA (Drugs)·D-0245-2016·2015-11-25
US Compounding Recalls Cyclo/PE/Tropic/Ketor Ophthalmic Drops for Sterility Concerns
US Compounding Inc is recalling 1,198 bottles of compounded ophthalmic drops nationwide due to deficient practices that may impact sterility assurance.
Product
Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0342-2016·2015-11-25
Downing Labs Recalls Ascorbic Acid Injectable Due to Sterility Concerns
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.
Product
Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0291-2016·2015-11-25
US Compounding Recalls Vancomycin Ophthalmic Preparations Due to Sterility Concerns
US Compounding Inc is recalling 494 syringes of Vancomycin Ophthalmic PF due to deficient practices that may impact sterility assurance.
Product
Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-299-2016·2015-11-25
Essential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections for Sterility Concerns
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised sterility assurance.
Product
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0153-2016·2015-11-25
Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination
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.
Product
Kar's Sweet n' Salty Mix 2 oz. flexible film bags. 72 bags per case.
Category
Food
Distribution
36 states
SevereFDA (Food)·F-0212-2016·2015-11-25
Front Row Produce Recalls Raw Cucumbers for Salmonella Risk
Front Row Produce LLC is recalling raw cucumbers in Missouri due to potential Salmonella contamination.
Product
Raw cucumbers packaged in bulk in 6-count corrugated boxes bearing the Front Row Produce logo. There is no city or state listed on the label.
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-0259-2016·2015-11-25
US Compounding Recalls Choline Chloride Inositol Cyanocobalamin Injection Vials
US Compounding Inc is recalling 103 vials of a compounded injection due to deficient practices that may impact sterility assurance.
Product
Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0237-2016·2015-11-25
Kronos Foods Recalls Sample Assortment for Potential Metal Fragments
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.
Product
Sample Assortment Net WT 4 lbs. (1.82 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11904 Manufactured by Kronos Foods Corporation, Madera, CA
Category
Food
Distribution
9 states
SevereFDA (Drugs)·D-322-2016·2015-11-25
Essential Wellness Pharma Recalls Progesterone Injection Due to Sterility Concerns
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.
Product
Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0237-2016·2015-11-25
US Compounding Recalls Alprostadil Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 82 vials of Alprostadil (PGE-1) nationwide due to deficient practices that may impact sterility assurance.
Product
Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0355-2016·2015-11-25
Downing Labs Recalls HCG Injectable Due to Sterility Assurance Concerns
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.
Product
HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0264-2016·2015-11-25
US Compounding Recalls Methylcobalamin Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.
Product
Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0285-2016·2015-11-25
US Compounding Recalls Triamcinolone/Lidocaine Vials Due to Sterility Concerns
US Compounding Inc is recalling 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.
Product
Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0383-2016·2015-11-25
Downing Labs Recalls MIC Injection Due to Sterility Assurance Concerns
Downing Labs, LLC is recalling MIC w/Methyl B-12 Preserved Injection vials because the company cannot assure the sterility of the product. The recall affects 49 vials distributed nationwide and internationally.
Product
MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0370-2016·2015-11-25
Downing Labs Recalls L-Glutathione Injection Due to Sterility Concerns
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.
Product
L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0366-2016·2015-11-25
Downing Labs Recalls B12 Injection Due to Sterility Assurance Concerns
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.
Product
B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0236-2016·2015-11-25
US Compounding Recalls Acetylcysteine 10% Ophthalmic Solution for Sterility Concerns
US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.
Product
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·15V799000·2015-11-25
Chrysler Recalls 2015 Ram ProMaster Vans for Ignition Switch Defect
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.
Product
RAM — RAM PROMASTER
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0242-2016·2015-11-25
US Compounding Recalls Bi-Mix Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 96 vials of Bi-Mix sterile preparations nationwide due to deficient practices that may impact sterility assurance.
Product
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0156-2016·2015-11-25
Kar Nut Products Recalls Golden Flake Trail Mix Due to Glass Contamination
Kar Nut Products Company is recalling Golden Flake Trail Mix because the product may contain very small pieces of glass.
Product
Golden Flake Trail Mix 2.25 oz. flexible film bags. 36 per case.
Category
Food
Distribution
36 states
SevereFDA (Drugs)·D-0345-2016·2015-11-25
Downing Labs Recalls Procaine Injectables Due to Sterility Concerns
Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.
Product
Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0254-2016·2015-11-25
US Compounding Recalls HCG/B12 Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 7,852 vials of HCG/B12 injection nationwide because deficient practices may have impacted sterility assurance.
Product
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0339-2016·2015-11-25
Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.
Product
L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-320-2016·2015-11-25
Essential Wellness Pharma Recalls Compounded Progesterone Injections for Sterility Concerns
Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised sterility assurance.
Product
Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-329-2016·2015-11-25
Essential Wellness Pharma Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections because poor sterile production practices resulted in a lack of sterility assurance.
Product
Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0350-2016·2015-11-25
Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.
Product
Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-334-2016·2015-11-25
Essential Wellness Pharma Recalls TRIMIX #3 Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Product
TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-319-2016·2015-11-25
Essential Wellness Pharma Recalls MIC Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling MIC Injection vials because poor production practices may have compromised the sterility of the finished drugs.
Product
MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-331-2016·2015-11-25
Essential Wellness Pharma Recalls Testosterone Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise sterility assurance.
Product
Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0286-2016·2015-11-25
US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns
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.
Product
Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0240-2016·2015-11-25
US Compounding Recalls Betamethasone SP Vials Due to Sterility Concerns
US Compounding Inc is recalling Betamethasone SP vials nationwide because deficient practices may have impacted sterility assurance.
Product
Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0357-2016·2015-11-25
Downing Labs Recalls EDTA Calcium Disodium Injectable Due to Sterility Concerns
Downing Labs is recalling 104 vials of EDTA Calcium Disodium Injectable because the company cannot assure the product's sterility.
Product
EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-312-2016·2015-11-25
Essential Wellness Pharma Recalls LIPO B Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of sterility assurance.
Product
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-323-2016·2015-11-25
Essential Wellness Pharma Recalls QUAD MIX Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling QUAD MIX Injection vials because poor sterile production practices may have compromised the sterility of the finished drugs.
Product
QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-333-2016·2015-11-25
Essential Wellness Pharma Recalls TRIMIX #2 Injection Due to Sterility Concerns
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.
Product
TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-316-2016·2015-11-25
Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.
Product
Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0260-2016·2015-11-25
US Compounding Recalls L-Cysteine PF Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,706 vials of L-Cysteine PF due to deficient practices that may impact sterility assurance.
Product
L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0284-2016·2015-11-25
US Compounding Recalls Triamcinolone Acetonide Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,244 vials of compounded Triamcinolone acetonide due to deficient practices that may impact sterility assurance.
Product
Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0288-2016·2015-11-25
US Compounding Recalls Tri-Mix Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 797 vials of Tri-Mix 30/1/10 injection due to deficient practices that may impact sterility assurance.
Product
Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-317-2016·2015-11-25
Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 25 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Product
Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0368-2016·2015-11-25
Downing Labs Recalls L-Arginine Injection Due to Sterility Concerns
Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.
Product
L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0359-2016·2015-11-25
Downing Labs Recalls DMPS Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling DMPS Injectable vials because the company cannot ensure the product is sterile.
Product
DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0276-2016·2015-11-25
US Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns
US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.
Product
Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0251-2016·2015-11-25
US Compounding Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
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.
Product
ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0283-2016·2015-11-25
US Compounding Recalls Trace Elements-4 IV Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact sterility assurance.
Product
Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0278-2016·2015-11-25
US Compounding Recalls Pilocarpine Ophthalmic Drops Due to Sterility Concerns
US Compounding Inc is recalling specific lots of Pilocarpine (1/16%) Ophthalmic drops because deficient practices may have impacted sterility assurance.
Product
Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0247-2016·2015-11-25
US Compounding Recalls Dapiprazole Ophthalmic Vials Due to Sterility Concerns
US Compounding Inc is recalling 2,984 bottles of compounded Dapiprazole ophthalmic vials nationwide due to deficient practices that may impact sterility assurance.
Product
Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0201-99
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0287-2016·2015-11-25
US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns
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.
Product
Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0258-2016·2015-11-25
US Compounding Recalls Hyaluronidase PF Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide due to deficient practices that may impact sterility assurance.
Product
Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0362-2016·2015-11-25
Downing Labs Recalls TNPDR Injection Buffered Due to Sterility Concerns
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.
Product
TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-335-2016·2015-11-25
Essential Wellness Pharma Recalls TRIMIX #4 Injection Due to Sterility Concerns
Kalman Health & Wellness is recalling TRIMIX #4 Injection vials due to poor sterile production practices that compromise sterility assurance.
Product
TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-306-2016·2015-11-25
Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns
Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.
Product
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0381-2016·2015-11-25
Downing Labs Recalls Magnesium Sulfate Injection Due to Sterility Concerns
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.
Product
Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-332-2016·2015-11-25
Essential Wellness Pharma Recalls TRIMIX #1 Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.
Product
TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-313-2016·2015-11-25
Essential Wellness Pharma Recalls LIPO-B Special Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling LIPO-B Special Injection vials because poor sterile production practices created a lack of sterility assurance.
Product
LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0367-2016·2015-11-25
Downing Labs Recalls Magnesium Chloride Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 289 vials of Magnesium Chloride Hexahydrate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Product
Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0238-2016·2015-11-25
US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.
Product
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0347-2016·2015-11-25
Downing Labs Recalls Vitamin D3 Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Vitamin D3 Injectable, 10,000 U/mL, 10mL vials due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Product
Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0271-2016·2015-11-25
US Compounding Recalls Neostigmine Syringes Due to Sterility Concerns
US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide due to deficient practices that may impact sterility assurance.
Product
Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0363-2016·2015-11-25
Downing Labs Recalls Calcium Gluconate Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.
Product
Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0241-2016·2015-11-25
US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 6,008 vials of Betamethasone SP PF due to deficient practices that may impact sterility assurance.
Product
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-309-2016·2015-11-25
Essential Wellness Pharma Recalls HCG Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling HCG 3000 Units/mL Injection vials due to poor sterile production practices that compromised sterility assurance.
Product
HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-336-2016·2015-11-25
Essential Wellness Pharma Recalls TRIMIX SPECIAL Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling TRIMIX SPECIAL Injection vials because poor sterile production practices created a lack of sterility assurance for the finished drugs.
Product
TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0375-2016·2015-11-25
Downing Labs Recalls Dexpanthenol Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 235 vials of Dexpanthenol Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.
Product
Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0351-2016·2015-11-25
Downing Labs Recalls Cyanocobalamin Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.
Product
Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0281-2016·2015-11-25
US Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns
US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP due to deficient practices that may impact sterility assurance.
Product
Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0272-2016·2015-11-25
US Compounding Recalls Omnipaque 300 Vials Due to Sterility Concerns
US Compounding Inc is recalling 8,218 vials of Omnipaque 300 injection due to deficient practices that may impact sterility assurance.
Product
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0292-2016·2015-11-25
US Compounding Recalls Vitamin D3 Vials Due to Sterility Concerns
US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil due to deficient practices that may impact sterility assurance.
Product
Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0275-2016·2015-11-25
US Compounding Recalls Phenylephrine Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 11 vials of Phenylephrine due to deficient practices that may impact sterility assurance.
Product
Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3289-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-318-2016·2015-11-25
Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 30 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Product
Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0239-2016·2015-11-25
US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.
Product
Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0230-2016·2015-11-25
Event Medical Recalls Inspiration Ventilators Due to Power Board Failure
Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.
Product
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-303-2016·2015-11-25
Essential Wellness Pharma Recalls Dexamethasone Ointment Due to Sterility Concerns
Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment because poor production practices may have compromised sterility.
Product
Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-301-2016·2015-11-25
Essential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns
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.
Product
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0249-2016·2015-11-25
US Compounding Recalls Dex Combo Sterile Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 854 vials of Dex Combo sterile injection due to deficient practices that may impact sterility assurance.
Product
Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-074-2016·2015-11-25
Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination
Kar Nut Products Company is recalling 74,333 boxes of Kar's Sweet n' Salty Mix due to the possibility of very small pieces of glass in the product.
Product
Kar's Sweet n' Salty Mix Box of 30, 2 oz. flexible film bags.
Category
Food
Distribution
36 states
SevereFDA (Drugs)·D-0369-2016·2015-11-25
Downing Labs Recalls DMSO 99% Injection Due to Sterility Concerns
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.
Product
DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0343-2016·2015-11-25
Downing Labs Recalls MICML TRNDPPC Injection Due to Sterility Concerns
Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure the product is sterile.
Product
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0230-2016·2015-11-25
Kanan Enterprises Recalls Cashews and Sweeties for Undeclared Milk
Kanan Enterprises is recalling 14-ounce bags of Kings fresh & Delicious Cashews & Sweeties because the product contains undeclared milk.
Product
Kings fresh & Delicious Cashews & Sweeties Net Wt. 14oz. (397g) INGREDIENTS: Cashews (Cashews, Canola and/or Peanut Oil Salt), CHOCOLATE BUTTONS (Sugar, Partially Hydrogenated Palm Kernel***King Nut Companies Solon, OH 44139 www.kingnut.com 0 38445 49999 8
Category
Food
Distribution
21 states
HighUSDA FSIS·143-2015·2015-11-25
Boyle's Famous Corned Beef Recalls Beef Top Round for Undeclared Wheat
Boyle's Famous Corned Beef Co. is recalling seasoned beef top round cases because the product contains undeclared hydrolyzed wheat protein, a known allergen.
Product
Boyle's Famous Corned Beef (2024), LLC — Boyle's Famous Corned Beef Co. Recalls Beef Products Due to Misbranding and Undeclared Allergen
Category
Food
Distribution
3 states
HighFDA (Food)·F-0206-2016·2015-11-25
National Frozen Foods Recalls Italian Vegetable Blend for Listeria Risk
National Frozen Foods Corporation is recalling Monarch and Valmont Italian Vegetable Blend due to potential Listeria monocytogenes contamination.
Product
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Item # 58108-03475 "***MONARCH***ITALIAN VEGETABLE BLEND CONTAINS ZUCCHINI, CARROTS, CAULIFLOWER, LIMA BEANS AND ITALIAN GREEN BEANS***NET WT***64 OZ***(U
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0151-2016·2015-11-25
Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination
Kar Nut Products Company is recalling 15,546 bags of Kar's Sweet n' Salty Mix due to the possibility that the product may contain very small pieces of glass.
Product
Kar's Sweet n' Salty Mix 16 oz. flexible film bags. 6 bags per case.
Category
Food
Distribution
36 states
HighFDA (Food)·F-0202-2016·2015-11-25
National Frozen Foods Recalls Italian Blend for Listeria Risk
National Frozen Foods is recalling Target-exclusive Italian Blend frozen vegetables due to potential Listeria monocytogenes contamination.
Product
Italian Blend. Product is IQF frozen, not ready to eat, each label carries cooking instruction. Label reads in part: "*** market pantry *** STEAM-IN-BAG Italian-Style Blend Broccoli, Cauliflower, Carrots, Italian-Style Green Beans & Zucchini*** NET WT 12 OZ***(UPC) 0 85239
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0233-2016·2015-11-25
Kronos Foods Recalls Natural Mini Caterer's Assortment for Metal Fragments
Kronos Foods is recalling Natural Mini Caterer's Assortment due to the potential for metal fragments in the baked goods.
Product
Natural Mini Caterer's Assortment Net WT 4 lbs. (1.81 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10169 Manufactured by Kronos Foods Corporation, Madera, CA
Category
Food
Distribution
9 states
HighFDA (Food)·F-0235-2016·2015-11-25
Kronos Foods Recalls Chocolate Almond Treasure Due to Metal Fragments
Kronos Foods is recalling Chocolate Almond Treasure because metal fragments were detected after increased metal detector rejections.
Product
Chocolate Almond Treasure Net WT 4 lbs. (1.81 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10932 Manufactured by Kronos Foods Corporation, Madera, CA
Category
Food
Distribution
9 states
HighFDA (Food)·F-0216-2016·2015-11-25
Vaughan Foods Recalls Sliced Cucumbers Due to Salmonella Contamination Risk
Vaughan Foods is recalling specific packages of sliced cucumbers due to a potential risk of Salmonella contamination. The products were distributed in six states.
Product
Sliced Cucumbers (100/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; Sliced Cucumbers (50/3 oz) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160; CU-2-Sliced Cucumbers (1/5 LB Tub) KEEP REFRIGERATED Made by: Vaughan Foods, Moore, OK 73160
Category
Food
Distribution
6 states
HighFDA (Food)·F-0262-2016·2015-11-25
Ocean's Halo Seaweed Chips Recalled for Gluten Contamination
New Frontier Foods is recalling Ocean's Halo Seaweed Chips because routine tests found gluten levels above the FDA limit for gluten-free products.
Product
Ocean's Halo, The Seaweed Chip. Sea Salt Flavor; 2.5 oz. bag Organic and Gluten Free ingredients. USDA Organic. Outer Case UPC: 10851899005174 Unit (Bag) UPC: 8 51899 00517 7 Distributed by New Frontier Foods, Inc. Burlingame, CA.
Category
Food
Distribution
3 states
HighFDA (Food)·F-0175-2016·2015-11-25
Kar's Sweet n' Salty Mix Recalled Due to Possible Glass Contamination
Kar Nut Products Company is recalling Kar's Sweet n' Salty Mix because the product may contain very small pieces of glass.
Product
Kar's Sweet n' Salty Mix Box of 5, 1.25 oz. flexible film bags. 6 boxes per case.
Category
Food
Distribution
36 states
HighFDA (Food)·F-0158-2016·2015-11-25
Lakeside Foods Recalls Frozen Peas and Carrots Due to Listeria
Lakeside Foods is recalling specific lots of frozen peas and carrots after testing confirmed the presence of Listeria monocytogenes.
Product
Frozen Peas & Carrots, Product is IQF, frozen, not ready to eat, each label carries cooking instructions. Product is packaged under the following brand names and sizes: 1. Bountiful Harvest, Net Wt.40 oz. (2.5 lbs.) 1.13 kg, UPC 22486-11902; 2. Giant Eagle, Net Wt 16 oz (1
Category
Food
Distribution
7 states
HighFDA (Food)·F-0197-2016·2015-11-25
Martinelli's Sparkling White Grape Recalled for Potential Glass Fragments
S. Martinelli & Co is recalling 8.4 oz bottles of Sparkling White Grape due to the potential for glass fragments.
Product
Martinelli's Sparkling White Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99925 5; item number 99925; Single 8.4 oz. bottle - UPC 0 41244 99025 2.
Category
Food
Distribution
3 states
HighFDA (Food)·F-0203-2016·2015-11-25
National Frozen Foods Recalls Italian Vegetable Blend for Listeria Risk
National Frozen Foods Corporation is recalling 32-ounce bags of First Street Italian Vegetable Blend due to potential Listeria monocytogenes contamination.
Product
Italian Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***FIRST STREET***ITALIAN BLEND CARROTS, CAULIFLOWER, ITALIAN GREEN BEANS, ZUCCHINI, LIMA BEANS*** NET WT 32 OZ***" UPC on bag 041512081958; Shipping Case UPC Co
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0208-2016·2015-11-25
National Frozen Foods Recalls Italian Vegetable Blend for Listeria Risk
National Frozen Foods Corporation is recalling frozen Italian Vegetable Blend due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***GARDEN FRESH***64775***47374***ITALIAN BLEND CONTAINS: ZUCCHINI, CARROTS, CAULIFLOWER, LIMAS, ITALIAN BEANS***20 LB NET WT***" No UPC on blue liner.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0152-2016·2015-11-25
Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination
Kar Nut Products Company is recalling Kar's Sweet n' Salty Mix 34 oz. bags due to the possibility of very small pieces of glass in the product.
Product
Kar's Sweet n' Salty Mix 34 oz. flexible film bags. 6 bags per case.
Category
Food
Distribution
36 states
HighFDA (Food)·F-0234-2016·2015-11-25
Kronos Foods Recalls Deluxe Assortment Baked Goods Due to Metal Fragments
Kronos Foods is recalling its Deluxe Assortment baked goods due to the potential for metal fragments. The recall affects 8 cases distributed in specific US states and Canada.
Product
Deluxe Assortment, Net WT 5 lbs. (2.27 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 10922 Manufactured by Kronos Foods Corporation, Madera, CA
Category
Food
Distribution
9 states
HighFDA (Food)·F-0154-2016·2015-11-25
Kar's Sweet n' Salty Mix Recalled for Possible Glass Contamination
Kar Nut Products Company is recalling 140,322 bags of Kar's Sweet n' Salty Mix due to the possibility that the product may contain very small pieces of glass.
Product
Kar's Sweet n' Salty Mix 3.5 oz. flexible film bags. 42 bags per case.
Category
Food
Distribution
36 states
HighFDA (Food)·F-0217-2016·2015-11-25
Vaughan Foods Recalls Taboli Product Due to Salmonella Contamination Risk
Vaughan Foods is recalling 98 cases of Taboli (80 oz) due to a potential Salmonella contamination risk. The product was distributed in six states.
Product
Taboli Net Wt. 80 oz (5 lb/2.82 kg) KEEP REFRIGERATED Manufactured by Fresh Creative Foods, Inc. Moore, OK 73160 in plastic tub
Category
Food
Distribution
6 states
HighFDA (Food)·F-0213-2016·2015-11-25
Hello Fresh Cucumbers Recalled for Potential Salmonella Contamination
Grocery Delivery E-Services USA, Inc. is recalling cucumbers from Hello Fresh meal kits due to potential Salmonella contamination.
Product
Cucumber, Super Select Unspecified variety packed in Hello Fresh box the week of August 24-28-2015 in the meal Spicy Tuna Tar-Tacos with Creamy Avocado and Cucumber Radish Slaw. 7-10 inches long, I cucumber per box.
Category
Food
Distribution
9 states
HighFDA (Food)·F-0209-2016·2015-11-25
National Frozen Foods Recalls Italian Vegetable Blend for Listeria Risk
National Frozen Foods Corporation is recalling frozen Italian Vegetable Blend due to potential Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Case"***Sysco Imperial ***FIESTA VEGETABLE BLEND***REORDER# ***8446007 *** 6/4 lb*** (UPC) 1 00 74865 52887 7***INGREDIENTS: Broccoli, Carrots, White Beans
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0200-2016·2015-11-25
Certified Smoked Fish Recalls Cold Smoked Salmon Trim for Listeria Risk
Certified Smoked Fish LLC is recalling 13 units of Cold Smoked Salmon Trim in California due to potential Listeria monocytogenes contamination.
Product
Cold Smoked Salmon Trim (CST50), 2 pcs, 2.5 lbs/case. 5lbs per case.
Category
Food
Distribution
1 state
HighFDA (Food)·F-0232-2016·2015-11-25
Kronos Foods Recalls Classic Baklava Due to Potential Metal Fragments
Kronos Foods is recalling Classic Baklava because metal fragments were detected during quality control. Consumers should stop eating the product and return it to the store.
Product
Classic Baklava; Net WT 5.5 lbs (2.43 kg) total weight of five trays bundled together. 38-68 pieces per tray Item number 11930 Manufactured by Kronos Foods Corporation, Madera, CA
Category
Food
Distribution
9 states

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