FDA Recall D-0764-2022
Adamis Pharmaceuticals Corporation · San Diego, CA
Class I — life-threatening Terminated 324 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 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 78670-131-02.
Reason for recall
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Recall record
- Recall number
D-0764-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide in the U.S.A.
- Recall initiated
- 2022-03-21
- Classified by FDA Center
- 2022-04-08
- FDA published
- 2022-04-13
- Terminated
- 2023-02-08
- Recalling firm
- Adamis Pharmaceuticals Corporation
- Firm location
- San Diego, CA