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:
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1. Lohxa LLC is voluntarily recalling one lot of Senna Syrup
8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled
due to microbial contamination.
Use
of contaminated product by the elderly, patients with a weakened immune system,
or patients at a higher risk of developing life-threatening inflammation of the
heart, could result in infections that could be life-threatening. To date,
Lohxa LLC has not received any reports of adverse events related to this
recall.
The
product is used as a natural vegetable laxative for the relief of occasional
constipation and is packaged into 5 mL unit-dose cups. The product is
distributed into cases of 20 cartons packaged with 24 units each, NDC:
50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration
date of 01/2023. The product can be identified by the label below. Product was
distributed to AvKare (Wholesaler) who may have further distributed this to
clinics, hospitals, and healthcare providers.
Outer carton labeling (see images below)
Unit-Dose Cups (see image below)
Lohxa
LLC is notifying its distributors and customers by letter and is arranging for
return of all recalled products. Consumers/distributors/retailers that have
product which is being recalled should stop using the product and return it to
place of purchase.
Consumers
with questions regarding this recall can contact Lohxa LLC by 800-641-5564 or by
email to info@lohxa.com Monday-Friday from 9am-5pm
EST. Consumers should contact their physician or
healthcare provider if they have experienced any problems that may be related
to taking or using this drug product.
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.
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2. Viona Pharmaceuticals Inc., is
voluntarily recalling twenty-three (23) lots
of Metformin
Hydrochloride Extended-Release Tablets, USP 750 mg at the consumer level. The
reason for the recall is an Out of Specification (OOS) result observed for one
lot of the product (M008132) “N-nitrosodimethylamine (NDMA) (By GC- MS/MS)”
test at 17 Month(s), 25°C/60%RH Long-term stability samples. In an abundance of
caution, the firm has decided to voluntarily recall 23 batches which we have
determined having a valid shelf life within the US market. This product was
manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S.
distribution by Viona Pharmaceuticals Inc.
Risk Statement: NDMA is classified as a
probable human carcinogen (a substance that could cause cancer) based on
results from laboratory tests. NDMA is a known environmental contaminant and
found in water and foods, including meats, dairy products, and vegetables.
Patients who have received impacted lots of Metformin Hydrochloride
Extended-Release Tablets, USP 750 mg are advised to continue taking their
medication and contact their physician for advice regarding an alternative
treatment. According to the FDA, it could be dangerous for patients with this
serious condition to stop taking their Metformin without first talking to their
healthcare professionals. Please visit the agency’s website for more
information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-
announcements-ndma-metformin. To date, neither Viona Pharmaceuticals
Inc., nor Cadila Healthcare Limited have received any reports of adverse events
related to this recall.
The product
is used as an adjunct to diet and exercise to improve blood glucose control in
adults with type 2 diabetes mellitus and is packaged in HDPE
bottles of 100 tablets, under NDC 72578-036-01. The recalled
lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are
listed in the below table. The product can be identified as white
to off-white, capsule shaped, uncoated tablets, debossed with "Z",
"C" on one side and "20" on the other side. Metformin
Hydrochloride Extended-Release Tablets, USP 750 mg was
distributed Nationwide to Distributors.
|
Product Name: Metformin Hydrochloride
Extended-Release Tablets, USP 750 mg |
||
|
Sr. No. |
Batch No. |
Exp. Date |
|
1. |
M008130 |
06/2022 |
|
2. |
M008131 |
06/2022 |
|
3. |
M008132 |
06/2022 |
|
4. |
M008133 |
06/2022 |
|
5. |
M010080 |
07/2022 |
|
6. |
M010081 |
07/2022 |
|
7. |
M011029 |
08/2022 |
|
8. |
M011030 |
08/2022 |
|
9. |
M011031 |
08/2022 |
|
10. |
M011032 |
08/2022 |
|
11. |
M011304 |
08/2022 |
|
12. |
M013394 |
09/2022 |
|
13. |
M013395 |
09/2022 |
|
14. |
M013396 |
09/2022 |
|
15. |
M013966 |
09/2022 |
|
16. |
M013967 |
09/2022 |
|
17. |
M100831 |
12/2022 |
|
18. |
M100832 |
12/2022 |
|
19. |
M100833 |
01/2023 |
|
20. |
M100834 |
01/2023 |
|
21. |
M101267 |
01/2023 |
|
22. |
M102718 |
01/2023 |
|
23. |
M102719 |
01/2023 |
Viona Pharmaceuticals Inc., is notifying its customers by email
and mail (FedEx Overnight) and is arranging for the return of
all recalled products to our recall processor at the following address
Inmar
Pharmaceuticals Services-Recalls
3845 Grand Lakes Way,
Grand Prairie, Texas 75050.
Consumers
with questions regarding this recall can contact our recall processor Inmar
Pharmaceutical Services by phone at 1-855-249-3303, option
1; Monday – Friday (excluding holidays), 9:00 am – 5:00 pm, EST. Consumers
should contact their physician or healthcare provider if they have experienced
any problems that may be related to taking or using this drug product.
Customers
with medical-related questions, who wish to report an adverse event, or quality
issues about the products being recalled should contact Viona
Pharmaceuticals Inc., by phone at: 888-304-5011, Monday -
Friday, 8:30 am – 5:30 pm, EST.
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.
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3. Poppies
International, Inc. of Battleboro, NC is expanding their voluntary recall to
include the Taste of Inspirations Crème Puffs 30ct container, UPC 7 25439 99597
9, Lot # L2I5021 Best Before Date 06/08/23 that were made during December 7-10,
2021, due to the possible presence of small metal fragments. The issue was
discovered during production. To date 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 |
|
Taste of
Inspirations Crème Puffs 30ct (375g) |
7 25439 99597 9 |
L2I5021 |
06/08/2023 |
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No
action is required of local health departments at this time for any of these
recalls. If any requests for assistance are received 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