D-0882-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 14, 2017
- Initiation Date
- April 13, 2017
- Termination Date
- February 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 container
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 2FD0376, Exp 02/21/21