CLASS II Drug recall · Reported 13 Aug 2014 · FDA Enforcement Report
Tetrahydrozoline HCL drum recalled by SST
SST is recalling Tetrahydrozoline HCL drum, distributed in California. The recall was initiated on 17 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-1517-2014
- FDA event ID
- 68891
- Recalling firm
- SST, Clifton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2014
- FDA classified
- 6 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 17 Jul 2014 | Recall initiated by company | |
| 6 Aug 2014 | Classified by FDA | +20 days |
| 13 Aug 2014 | Published in enforcement report | +7 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 HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Where it was distributed
CA
Questions about this recall
Is Tetrahydrozoline HCL drum recalled?
Yes. SST recalled Tetrahydrozoline HCL drum on 17 Jul 2014. The recall is Class II and its status is Terminated. Recall number D-1517-2014.
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: 168.862, Expiry: 6/2017
Where was it sold?
CA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.