FDA-Drug2013-10-30Class III
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
Hi-Tech Pharmacal Co., Inc.
Hazard
Subpotent; phenylephrine HCl
Sold states
Puerto Rico
Affected count
50,848 bottles (total for 3 lots)
Manufactured in
369 Bayview Ave, N/A, Amityville, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66207-001Don't want to check this manually?
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