FDA recall D-0392-2024

Product

Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01

Reason for recall

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-03-12

Report date

2024-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cherry Hill, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2024