FDA recall D-0763-2022

Product

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

Reason for recall

Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.

Distribution

Nationwide in the U.S.A.

Key facts

Status

Terminated

Initiation date

2022-03-21

Report date

2022-04-13

Termination date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0763-2022