D-0255-2015 Class II Terminated
FDA drug recall D-0255-2015 was initiated by Spectrum Laboratory Products on July 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 November 24, 2014). Affected quantity: 16 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2014
- Initiation Date
- July 18, 2014
- Termination Date
- November 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