SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, M
Summary
The FDA issued a Class I for SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Sin by Adamis Pharmaceuticals Corporation. Reason: Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine..
Details
Source
Drug Recall
External ID
D-0763-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
Product Description
SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
Lot/Code Info: Lot #: 21041W, Exp. 8/31/2022; 21081W, Exp. 11/30/2022; 21102W, Exp. 2/28/2023
Quantity Affected: 25,103 cartons
Reason for Recall
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Distribution
Nationwide in the U.S.A.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-21
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Adamis Pharmaceuticals Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Adamis Pharmaceuticals Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Adamis Pharmaceuticals Corporation have FDA actions?
Adamis Pharmaceuticals Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0763-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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