FDA recall D-0327-2022

Product

PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L

Reason for recall

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Distribution

Product was distributed to one customer who may have further distributed the product.

Key facts

Status

Terminated

Initiation date

2021-11-29

Report date

2022-01-12

Termination date

2023-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Highland, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2022