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. .

Recall Number: D-0803-2016

Firm: Meditech Laboratories, Inc

Classification: Class II

Status: Terminated

Report Date: 20160413

Initiation Date: 20160314

Termination Date: 20160607

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

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. .