Reported Oct 30, 2013 · Terminated
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08),…
Hi-Tech Pharmacal Co., Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hi-Tech Pharmacal Co., Inc. · 369 Bayview Ave · Amityville, NY · 11701-2801
Is this the product you have?
- 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 forGIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716
- Lot codes and dates
- 1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl
- ozBatch/Lot 615649 (exp. 05/2014)
- Amount recalled
- 50,848 bottles (total for 3 lots)
Where it was sold
Why it was recalled
Subpotent; phenylephrine HCl
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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