FDA recall D-0538-2022

Product

HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00

Reason for recall

CGMP Deviations

Distribution

Bulk product was distributed to 3 distributors who may have distributed finished product.

Key facts

Status

Terminated

Initiation date

2022-01-26

Report date

2022-02-16

Termination date

2025-01-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Highland, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0538-2022