Please review the
following message from Alan Talarsky, Environmental Scientist 4, Public Health
and Food Protection Program, NJDOH regarding the following Class 1 Recalls
issued by the U.S. Food and Drug Administration:
1. SEVIROLI FOODSA INC., of Garden City is recalling Aplenty
Rotini with Plant Based Bolognese Meal Kit due to an undeclared allergen –
milk in the product.
The affected products were sold through Amazon
Fresh stores and Fresh online channels and distributed throughout the US.
The issue was discovered on December 22, 2021.
The recall was initiated after discovering that Seviroli Foods products
containing milk were inadvertently packaged in Aplenty-Rotini with Plant Based
Bolognese Meal Kit packaging, which does not include milk in the ingredient
statement. No related illnesses or incidents have been reported to date. All
product related to this recall has been removed from Amazon store shelves.
The following products, with the specific lot
numbers, are subject to recall:
|
Item # |
UPC # |
Item Description |
Lot Code |
Sell by Date |
|
19759 |
842379197598 |
Aplenty Rotini with Plant based
Bolognese |
1148 |
May 28,2022 |
|
1161 |
June
10,2022 |
|||
|
1162 |
June 11, 2022 |
Code is located on the back of the back,
bottom center. Consumers who have an allergy or severe sensitivity to milk run
the risk of serious or life-threatening allergic reaction if they consume this
product.
Customers with any questions or concerns may
contact Seviroli Customer Service at 516-222-6220 Ext 111 Monday through
Friday from 8 a.m. to 6 p.m. Central Standard Time. Anyone concerned about an
injury or illness should contact a healthcare provider.
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2. Padagis
US LLC announced it has issued a voluntary nationwide recall to the
consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the
table below. Out of an abundance of caution, this product is being recalled
from the market due to a complaint received that a unit may not dispense. There
is a remote risk that the product may not properly dispense medication to
patients in the event of a malfunction of their dispensing unit. This recall
applies only to the 12g spray bottle and not the 4.9g spray bottle of this
medication.
|
Drug |
NDC |
Strength |
Net Contents |
Lot # |
Expiration |
|
Nitroglycerin |
45802-210-02 |
400 mcg per |
12 g |
150892 |
Oct 2022 |
|
153199 |
Feb 2023 |
||||
|
156041 |
Apr 2023 |
Risk Statement: If the product does not
deliver the appropriate amount of nitroglycerin, the patient will likely
continue to experience chest pain. The label advises that if relief is not
obtained after 3 doses over 15 minutes the patient should promptly seek medical
attention. To date, Padagis has not received any reports of adverse events
related to this recall.
Nitroglycerin
Lingual Spray is indicated for acute relief of an attack or prophylaxis of
chest pain due to coronary artery disease in adult patients. All packaging and
branding on affected units is that of Perrigo Company PLC. The product is
packaged in a 12 g bottle contained within a carton. The medication was
distributed Nationwide in the USA to wholesalers and retailers.
Padagis
is notifying its distributors and customers by express package delivery service
as well as electronic mail and is arranging for return of all recalled
products. This recall is being directed at the consumer/user level. All
customers, healthcare providers, and consumers are instructed to examine their
inventory for Nitroglycerin Lingual Spray, 12g immediately and to quarantine,
discontinue the distribution and use of, and return as directed all recalled
lots of the product. Customers and healthcare providers are being provided
recall information by Sedgwick Claims Management Services. All customers who
have distributed this product to consumers have been requested to identify
their customers and notify them immediately of this product recall. Healthcare
providers, distributors, and retailers that have product which is being
recalled should stop distribution. Patients who have this product should
contact their healthcare provider for an alternate replacement before returning
the recalled product. The necessary form to document product information, as
well as other information, is available by contacting Sedgwick at padagis5665@sedgwick.com or 888-266-7912.
Patients
with questions regarding this recall can contact 888-266-7912 M-F 8am – 5pm EST. Patients
should contact their physician or healthcare provider if they have experienced
any problems that may be related to using this product or any medical concerns.
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.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
**************************************************************************************************
3. Poppies
International, Inc. of Battleboro, NC is issuing a voluntary recall of selected
products that were made during December 7-10, 2021, due to the possible
presence of small metal fragments. The issue was discovered during production.
No injuries or incidents have been reported in connection with the recalled
items. See below for product list, UPCs, and “best before” dates, which may be
found on the side of the containers.
Any
consumers who have purchased or received any of the products described below should
immediately discontinue use of the product and return it to the place of
purchase for a full refund. Consumers with questions may contact the company at info@delizza.us or 252-428-7118, Monday
through Friday between 9am-5pm EST.
More information can be found at www.delizza.us/press
The product included in the recall was available for sale from
December 16-23, 2021 and can be identified by the lot numbers and best before
dates which can be found on the side of each tub by the lid:
|
Description |
UPC |
Lot Codes |
Best Before Date |
|
Delizza Choc Enrobed 30 ct (400g) |
6 76670 00402 2 |
L1J5021 |
06/09/2023 |
|
Delizza Cream Puffs
30 ct (375g) |
6 76670 00107 6 |
L2N5021 |
06/10/2023 |
|
Delizza Cream Puffs 120 ct (1.5 kg) |
6 76670 00800 6 |
L32E5021 |
06/07/2023 |
4. HAIFA
SMOKED FISH of Jamaica, NY is expanding their recall of Turbot Cold Smoked 8 oz
Packages to include 920 LB of Turbot from Lots 97, 223, 299, 321. The products
have the potential to be contaminated with Listeria monocytogenes,
an organism which can cause serious and sometimes fatal infections in young
children, frail or elderly people, and others with weakened immune systems.
Although healthy individuals may suffer only short-term symptoms such as high
fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection
can cause miscarriages and stillbirths among pregnant women.
The following lots of Turbot Cold Smoked 8z
Lots are being recalled:
Lot #97
Lot #223
Lot #246 (original recall)
Lot #299
Lot #321
The above lots of TURBOT COLD SMOKED 8 OZ were
distributed to retail stores in New York and New Jersey Areas.
The product is packaged in clear plastic with
a gold board that contains sliced Cold Smoked Turbot fish with a blue label
that reads “Haifa Smoked Fish & Caviar Turbot Cold Smoked” Net wt. 8
oz/227g. Ingredients: Turbot, Salt and Natural wood smoke. On the back of the
board, it will display a sticker that reads “LOT # 97; LOT #223; LOT #246; LOT
# 299; LOT # 321.”
No illnesses have been reported up to date.
Consumers who have purchased Turbot Cold
Smoked 8 oz Package LOTS # 97, 223, 246, 299, 321 are urged to return it to the
place of purchase for a full refund.
Consumers with question may contact the
company at 718 523-8899. Our hours of operation are Monday thru Friday 9am to
5pm Eastern Standard Time. Contact name: Dmitriy Yakubbayev.
************************************************************************************************
No
action is required of local health departments at this time for any 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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For all recalls -
http://www.recalls.gov/recent.html
This information has been broadcast to: Food Safety Organizations; NJLINCS and Local Contacts; NJLINCS Community; Public Health Sector; Local Boards of Health; NJDOH Staff; Public Health Associations; Public Health Council