Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.

Recall Number: D-1422-2019

Firm: Premier Pharmacy Labs Inc

Classification: Class II

Status: Terminated

Report Date: 20190703

Initiation Date: 20190618

Termination Date: 20211026

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.