Drug Enforcement D-66207-001

Subpotent; phenylephrine HCl

Status

Terminated

Classification

Class III

Report Date

October 30, 2013

Termination Date

April 29, 2015

Product Information

Product description
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
Product quantity
50,848 bottles (total for 3 lots)
Reason for recall
Subpotent; phenylephrine HCl
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Puerto Rico

Location & Firm

Recalling firm
Hi-Tech Pharmacal Co., Inc.
Address
369 Bayview Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-66207-001
Event ID
66207
Recall initiation date
September 4, 2013
Center classification date
October 22, 2013
Code info
1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).
More code info
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