Category Archives: Heath Forum

Food Recall

NJLINCS Health Alert Network

Public Health Info

Distributed by the New Jersey Department of Health

Subject: Food Recall

Empire Kosher Poultry, Inc., a Mifflintown, Pa. establishment, is recalling approximately 10,839 pounds of raw poultry products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced.

The raw chicken breast products were produced and packaged on Nov. 2, 2017. The following products are subject to recall:

.4 to5.25-lbs. tray packages containing chicken breasts labeled “Empire KOSHER NATURAL Chicken Breasts, Boneless & Skinless” with case code 46375 and “Sell By” date 11/14/17.
.1 to1.25-lbs. tray packages containing chicken breasts labeled “Empire KOSHER NATURAL Chicken Breasts, Boneless & Skinless” with case code 7488 and “Sell By” date 11/16/17.
.2.5-lbs. tray packages containing chicken breasts labeled “Empire KOSHER NATURAL Chicken Breasts, Boneless & Skinless” with case code 7598 and “Sell By” date11/16/17.
.1 to1.25-lbs. tray packages containing chicken breasts labeled “Empire KOSHER NATURAL Chicken Breasts, Boneless & Skinless” with case code 92615 and “Sell By” date 11/17/17.
.1 to 1.25 -lbs. tray packages containing chicken breasts labeled “Empire KOSHER NATURAL Chicken Breasts, Boneless & Skinless” with case code 7888 and “Sell By” date 11/16/17.

The products subject to recall bear establishment number “P-1015” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.

The problem was discovered on November 2, 2017 by an establishment employee who observed metal foreign material in a chicken breast while performing routine duties. The establishment took corrective actions to recover products before reaching commerce.

There have been no confirmed reports of adverse reactions due to consumption of these products. FSIS has received no reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact the Empire Kosher toll free line at (800) 570-5718. Media with questions about the recall can contact MediaRelations@Hain.com.

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For all recalls – http://www.recalls.gov/recent.html

Project Medicine Drop

Recall of Wholesale & Retail Liquid Products and Liquid Vitamin Supplements Manufactured by PharmaTech

8-17-2017            Recall of Wholesale and Retail liquid products and liquid vitamin supplements manufactured by PharmaTech

Distribution firms: Leader Brand, Major Pharmaceuticals and Rugby Laboratories, have jointly issued a precautionary nationwide recall on August 3rd, 2017 of all lots of liquid products manufactured by PharmaTech LLC, of Davis, Fl. Due to possible product contamination of Burkholderia cepacia (B. cepacia).  People who may have a weakened or developing immune systems or chronic lung disease like cystic fibrosis are most susceptible to bacterial infection that is often resistant to common antibiotics (CDC, 2016). High risk populations include infants, children, and the elderly, who may be more likely to use liquid products.  

Products subject to recall were distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories to both wholesale and retail facilities, including hospitals and pharmacies. Consumers, pharmacies, and healthcare facilities that have products which include but are not limited to, Diocto Syrup and Dioctor Liquid, should stop using and dispensing product immediately.

Consumers with questions regarding this recall should contact Rugby Laboratories/ Major Pharmaceuticals Customer Support at 1-800-645-2158, Monday through Friday 8 a.m- 8 p.m EST. Or Leader Customer Support at 1-800-200-6313 option #1, Monday through Thursday 8 a.m – 7 p.m and Friday 8 a.m – 5 p.m EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

  • Complete and submit the report Online: fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

Please see the below list of affected products:

LEADER BRAND

Liquid Multivitamin Supplement for Infants and Toddlers 50 mL,

UPC: 096295128611

ALL LOTS

Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL,

UPC: 096295128628

ALL LOTS

MAJOR PHARMACEUTICALS

Certa-Vite Liquid

236ML

00904-5023-09

ALL LOTS

Poly-Vita Drops

50ML

00904-5099-50

ALL LOTS

Poly-Vita Drops W/Iron

50ML

00904-5100-50;

ALL LOTS

Ferrous Drops Iron Supp

50ML

00904-6060-50

ALL LOTS

D-Vita Drops

50ML

00904-6273-50

ALL LOTS

Tri-Vita Drops

50ML

00904-6274-50

ALL LOTS

Senna Syrup

237ML

00904-6289-09

ALL LOTS

 

RUGBY LABORATORIES

C Liquid 500mg

118ML

00536-0160-97

ALL LOTS

Diocto Liquid 50mg/5ml

473ML

00536-0590-85

ALL LOTS

Ferrous Sulfate Elixir

473ML

00536-0650-85

ALL LOTS

Fer Iron Liquid 50ML

50ML

00536-0710-80

ALL LOTS

Senexon Liquid

237ML

00536-1000-59

ALL LOTS

Diocto Syrup 60MG/15ML

473ML

00536-1001-85

ALL LOTS

Aller Chlor Syrup

120ML

00536-1025-47

ALL LOTS

Calcionate Syrup

16OZ

00536-2770-85

ALL LOTS

Cerovite Liquid

236ML

00536-2790-59

ALL LOTS

D3 400iu Liquid

50ML

00536-8400-80

ALL LOTS

Poly-Vitamin Liquid

50ML

00536-8450-80

ALL LOTS

Tri-Vitamin Liquid

50ML

00536-8501-80

ALL LOTS

Poly-Vitamin W/Iron Liquid

50ML

00536-8530-80

ALL LOTS

 

 

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RECALLS

NJLINCS Health Alert Network

Public Health Info

Distributed by the New Jersey Department of Health


 1. Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

U.S. Impacted Lots:

Product/Dosage

NDC Number

Lot Number

Expiration Date

EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

5GN767

April 2017

EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

5GN773

April 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

5GM631

April 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

5GM640

May 2017

EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

6GN215

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM082

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM072

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM081

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM088

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM199

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM091

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM198

October 2017

EpiPen 2-pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM087

October 2017

Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. The firm is asking patients to keep their existing product until their replacement product can be secured.

Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.

To return your product please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

.Complete and submit the report Online: www.fda.gov/medwatch/report.htm
.Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This voluntary recall is being conducted with the knowledge of FDA.

Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.

More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.

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2. Conagra Brands, Inc., announced that it is voluntarily recalling a limited amount of Hunt’s Chili Kits due to the potential presence of Salmonella in the chili seasoning packet contained in the kit. The chili seasoning used in the packet originated from a supplier who informed the company of the potential presence of Salmonella in a raw material used in the chili seasoning. Although no Salmonella was found in the finished product supplied to Conagra Brands, the company has decided out of an abundance of caution to recall the product.

There have been no reports of adverse reactions or injuries due to consumption of this product to date. Salmonella is a bacterium that can cause diarrhea, fever and abdominal cramps. Most individuals recover without treatment. In some cases, diarrhea may be so severe that the patient needs to be hospitalized. The elderly, infants and those with impaired immune systems are more likely to have a severe illness.

The product covered by this recall was distributed in retail stores, military commissaries and online nationwide in the U.S.: the specific product information is listed below. The product code information is stated on the bottom of the kit below the barcode. No other Hunt’s products or Conagra Brands’ products are impacted by this recall.

Item Description

UPC

MFG/Lot Code

Best By Date

HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619500 Apr 04, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534622200 May 01, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619600 Apr 05, 2018

Consumers who have purchased this item are advised not to consume it and return it to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Affairs hotline at 1-800-921-7404, open 9 am through 5 pm CDT, Monday through Friday.

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No action is required of local health departments at this time for either of these recalls. If any requests for assistance are received from FDA, the Public Health and Food Protection Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below.

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