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
Reported: October 30, 2013 Initiated: September 4, 2013 #D-66207-001
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
Reason for Recall
Subpotent; phenylephrine HCl
Details
- Recalling Firm
- Hi-Tech Pharmacal Co., Inc.
- Units Affected
- 50,848 bottles (total for 3 lots)
- Distribution
- Puerto Rico
- Location
- Amityville, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 50,848 bottles (total for 3 lots).
Why was this product recalled? ▼
Subpotent; phenylephrine HCl
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 30, 2013. Severity: Low. Recall number: D-66207-001.
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