FDA recall D-0527-2022

ULTRAtab Laboratories, Inc. · Class II · drug

Product

Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00

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-0527-2022