Drug product
Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
D-0255-2015
Product summary
- Event
- Event 69808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 Bottles
- Official record key
drug-enforcement:D-0255-2015
Official wording
Reason: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Code information: Lot #: 1BJ0479; Expiry: 06/2017
Distribution pattern: U.S.: California.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations