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.
Recall initiated: 20160314
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated