The Recall Desk
ModerateFDA (Drugs)·D-66207-001·Announced 2013-10-30

Hi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines

Hi-Tech Pharmacal is recalling specific lots of Giltuss and Exactuss cough and cold medicines because they contain less phenylephrine than labeled.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences, aligning with the Moderate severity rubric for minor labeling or potency issues.

Plain-English summary

Hi-Tech Pharmacal Co., Inc. is recalling 50,848 bottles of Giltuss Antitussive Expectorant and Nasal Decongestant (1 fl. oz. and 8 fl. oz.) and Exactuss Antitussive Expectorant and Nasal Decongestant (16 fl. oz.). The products were manufactured for Gil Pharmaceutical Corp. and distributed in Puerto Rico.

The recall was initiated because the affected lots are subpotent, meaning they contain less phenylephrine HCl than the amount stated on the label. The specific lots involved are Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014) for the 1 fl. oz. and 8 fl. oz. sizes, and Batch/Lot 615649 (exp. 05/2014) for the 16 fl. oz. size.

Consumers who have these specific products should stop using them and return them to the place of purchase or contact the recalling firm for instructions.

The recalled product

Product
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 0071
Manufacturer
Hi-Tech Pharmacal Co., Inc.
Category
Drug — Cough and Cold Medicine
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).

Distribution

Distributed in 1 state:

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