CLASS III Drug recall · Reported 30 Oct 2013 · FDA Enforcement Report
Giltuss Antitussive Expectorant And Nasal Decongestant recalled
Hi-Tech Pharmacal is recalling Giltuss Antitussive Expectorant And Nasal Decongestant (, distributed in Puerto Rico. The recall was initiated on 4 Sep 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-66207-001
- FDA event ID
- 66207
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Sep 2013
- FDA classified
- 22 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 4 Sep 2013 | Recall initiated by company | |
| 22 Oct 2013 | Classified by FDA | +48 days |
| 30 Oct 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; phenylephrine HCl
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent; phenylephrine HCl
Which lots are affected?
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).
Where was it sold?
Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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