Drug product
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
D-0882-2017
Product summary
- Event
- Event 77398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 container
- Official record key
drug-enforcement:D-0882-2017
Official wording
Reason: CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Code information: Lot #: 2FD0376, Exp 02/21/21
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations