MAUDE Adverse Event Report: AMNEAL PHARMACEUTICALS EPINEPHRINE INJECTOR PEN; PISTON, SYRINGE

Lot Number G191009X

Device Problems Nonstandard Device (1420); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  No Answer Provided  

Event Description

Reporter stated that they received a letter from their supplier (b)(4), that an epinephrine injector pen lot#g191009x has been recalled.Reporter also stated that the medication was not dispensed.

• Brand Name: EPINEPHRINE INJECTOR PEN
• Type of Device: PISTON, SYRINGE
• Manufacturer (Section D): AMNEAL PHARMACEUTICALS; 400 crossing boulevard; 3rd floor; bridgewater NJ 08807
• MDR Report Key: 10173827
• MDR Text Key: 196066523
• Report Number: MW5095081
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: G191009X
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1