FDA recall D-0199-2018

Product

Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Distribution

Nationwide in the USA, Bermuda, and New Zealand

Key facts

Status

Terminated

Initiation date

2017-11-16

Report date

2018-01-17

Termination date

2020-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0199-2018