D-0255-2015 Class II Terminated
FDA drug recall D-0255-2015 was initiated by Spectrum Laboratory Products on Jul 18, 2014 and is designated Class II. Reason for recall: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. The recall status is terminated (terminated Nov 24, 2014). Affected quantity: 16 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 26, 2014
- Initiation Date
- Jul 18, 2014
- Termination Date
- Nov 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 Bottles
Product Description
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.
Distribution Pattern
U.S.: California.
Code Information
Lot #: 1BJ0479; Expiry: 06/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0255-2015
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026