FDA recall D-66207-001

Hi-Tech Pharmacal Co., Inc. · Class III · drug

Product

GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716

Reason for recall

Subpotent; phenylephrine HCl

Distribution

Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-09-04
Report date: 2013-10-30
Termination date: 2015-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66207-001