FDA recall D-0803-2016

Product

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

Reason for recall

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-03-14

Report date

2016-04-13

Termination date

2016-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2016