FDA recall D-0129-2018

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-10

Report date

2017-12-27

Termination date

2018-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weeki Wachee, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0129-2018