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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 29, 2015 · Data as of Sep 19, 5:06 PM UTC

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