FDA Drug recall D-0255-2015
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle
- FDA Drug
- Class II
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class II recall of Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle by Spectrum Laboratory Products, citing CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0255-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-18 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Spectrum Laboratory Products |
| Distribution | CA |
Product
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Reason
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Identifiers
| code_info | Lot #: 1BJ0479; Expiry: 06/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Spectrum Laboratory Products
- Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G
FDA Drug · Class I · 2023-02-01 · Spectrum Laboratory Products - Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg
FDA Drug · Class I · 2023-02-01 · Spectrum Laboratory Products - Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams…
FDA Drug · Class II · 2020-02-12 · Spectrum Laboratory Products - Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol
FDA Drug · Class II · 2020-01-01 · Spectrum Laboratory Products - Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
FDA Drug · Class II · 2019-10-23 · Spectrum Laboratory Products
All Spectrum Laboratory Products recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0255-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.