FDA recall D-0496-2019

Product

Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72

Reason for recall

Labeling: Incorrect expiration date.

Distribution

PA

Key facts

Status

Terminated

Initiation date

2019-02-06

Report date

2019-02-27

Termination date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0496-2019