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