CLASS II Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Tetrahydrozoline Hydrochloride recalled by Spectrum Laboratory Products
Spectrum Laboratory Products is recalling Tetrahydrozoline Hydrochloride, USP, distributed in California. The recall was initiated on 18 Jul 2014 and the FDA has classified it as Class II.
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-0255-2015
- FDA event ID
- 69808
- Recalling firm
- Spectrum Laboratory Products, Gardena, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2014
- FDA classified
- 20 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 18 Jul 2014 | Recall initiated by company | |
| 20 Nov 2014 | Classified by FDA | +125 days |
| 26 Nov 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Product as listed by the FDA
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Where it was distributed
U.S.: California.
Questions about this recall
Why was it recalled?
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Which lots are affected?
Lot #: 1BJ0479; Expiry: 06/2017
Where was it sold?
U.S.: California.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Spectrum Laboratory Products
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Ranitidine Hydrochloride (powder) recalled | Spectrum Laboratory Products | Nitrosamine Impurity | 11 states |
| Drug | CLASS II | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol recalled | Spectrum Laboratory Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled | Spectrum Laboratory Products | Foreign Material | 4 states |
Other Tetrahydrozoline recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%) recalledGoodsense Eye Drops Original Formula | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Original Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original Formula | K.C. Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Eye Drops (Tetrahydrozoline HCl 0.05%), Over the Counter recalledSunmark Eye Drops Original Formula | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |