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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