FDA recall D-0804-2016

Meditech Laboratories, Inc · Class II · drug

Product

Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, 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-0804-2016