FDA recall D-0067-2019

Product

Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.

Reason for recall

Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-08-03

Report date

2018-10-24

Termination date

2021-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Daytona Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0067-2019