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.

Recall Number: D-0882-2017

Firm: Spectrum Laboratory Products, Inc.

Classification: Class II

Status: Terminated

Report Date: 20170614

Initiation Date: 20170413

Termination Date: 20190221

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.

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.