FDA recall D-1004-2015

Product

Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Reason for recall

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Distribution

NC

Key facts

Status

Terminated

Initiation date

2015-02-12

Report date

2015-05-20

Termination date

2017-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Southern Pines, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1004-2015