Tetrahydrozoline Hydrochloride — Class II drug recall D-0255-2015
Terminated recall by Spectrum Laboratory Products, reported 2014-11-26, distributed in CA. CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
| Recall number | D-0255-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Laboratory Products, Gardena, CA, United States |
| Recall initiated | 2014-07-18 |
| Classified | 2014-11-20 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2014-11-24 |
| Distributed | CA |
| Quantity | 16 bottles |
| Reason classes | cgmp |
| Lot numbers | 1BJ0479 |
| Model numbers | YY1568 |
| Expiration dates | 2017-06 |
Product
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Reason for recall
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0255-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.