Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Recall Number: D-0807-2016

Firm: Meditech Laboratories, Inc

Classification: Class II

Status: Terminated

Report Date: 20160413

Initiation Date: 20160314

Termination Date: 20160607

Reason for Recall

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

Product Description

Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.