FDAFDA · Food and drugs·Recall number D-66207-001
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
Published October 30, 2013 · Recall initiated: September 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent; phenylephrine HCl
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Distributor
- Puerto Rico
- Lot
- 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).
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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