Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (epinephrine) Injection for Potential Manufacturing Defect
21 Marzo 2022 - 2:05PM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is
voluntarily recalling certain lots of SYMJEPI (epinephrine)
Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL)
Pre-Filled Single-Dose Syringes to the consumer level. The batches
in the table below are being recalled due to the potential clogging
of the needle preventing the dispensing of epinephrine. US
WorldMeds (USWM) exclusively markets and distributes SYMJEPI in the
United States, under license from Adamis, the NDA holder. USWM will
handle the entire recall process for Adamis, with Adamis oversight.
SYMJEPI is manufactured and tested for Adamis by Catalent Belgium
S.A.
Risk Statement:If a person is experiencing an
allergic reaction and/or anaphylaxis and is unable to access
life-saving epinephrine due to the syringe malfunction, it can lead
to life threatening consequences including death. Although not
confirmed to be related to the recall, there have been two
different customer complaints on three syringes, regarding
difficulty in dispensing the product, to date. However, neither US
WorldMeds nor Adamis Pharmaceuticals has received, or is aware of,
any adverse events related to this recall.
The recall encompasses all of the following batches, within
expiry:
Product |
Strength |
NDC |
Lot |
Expiration |
SYMJEPI (epinephrine) Injection |
0.15 mg/0.3 mL |
78670-131-02 |
21101Y |
11/30/2022 |
0.3 mg/0.3 mL |
78670-130-02 |
21041W |
8/31/2022 |
21081W |
11/30/2022 |
21102W |
2/28/2023 |
SYMJEPI is indicated in the emergency treatment of allergic
reactions (Type I) including anaphylaxis to stinging insects (e.g.,
order Hymenoptera, which include bees, wasps, hornets, yellow
jackets, and fire ants) and biting insects (e.g., triatoma,
mosquitoes), allergen immunotherapy, foods, drugs, diagnostic
testing substances (e.g., radiocontrast media) and other allergens,
as well as idiopathic anaphylaxis or exercise-induced
anaphylaxis.
The products are packaged in 2-count Pre-Filled Single-Dose
Syringes per carton and were distributed nationwide in the USA and
directly to customers and/or medical facilities. The products can
be identified by the label containing the US WorldMeds name and
logo pictured on the cartons in the links below.
https://www.globenewswire.com/NewsRoom/AttachmentNg/f0f35ae4-e825-4d67-9ea9-9fb51301c3ac
https://www.globenewswire.com/NewsRoom/AttachmentNg/228b0c14-6113-4f61-8499-0e1b574435c5
US WorldMeds is notifying its customers by email, FDA alerts,
and direct outreach. Consumers and institutions that have products
that are subject to this recall should stop using the products
immediately and may either return or discard the recalled lots.
Consumers with questions regarding this recall can call (888)
900-8796 or e-mail questions at medinfo@usworldmeds.com
Monday-Friday from 8:00 am to 4:00 pm ET.
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
- Regular Mail or Fax: Download form 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 recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
Adamis Contacts:
Quality ComplianceCraig StenlandQuality Compliance
Partners858-361-6456craigs@qualpartners.com
Investor RelationsRobert UhlManaging DirectorICR Westwicke
619.228.5886robert.uhl@westwicke.com
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