Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
SYMJEPI (epinephrine injection, USP)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
78670-0130-02
Compare with the code on your package — it is the most precise check available.
Drug: Epinephrine
- Recalling firm
- Adamis Pharmaceuticals Corporation
- NDC code
- 78670-130-02
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0763-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Epinephrine recalls
See all
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other recalls by Adamis Pharmaceuticals Corporation
All 2022 recalls
Class I · High risk
SYMJEPI (epinephrine injection, USP)
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
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