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Recall Observatory FDA recall evidence

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

April 13, 2017

Class II

Product summary

Firm
Spectrum Laboratory Products, Inc.
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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations