Premier Pharmacy Labs Inc recalls Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounde…

Recall date

August 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0129-2018

FDA classification

Class II

Brand / firm

Premier Pharmacy Labs Inc

Sold / distributed

Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida

Why it was recalled

Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15