FDAFDA · Food and drugs·Recall number D-0882-2017
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.
Published June 14, 2017 · Recall initiated: April 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spectrum Laboratory Products, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 2FD0376, Exp 02/21/21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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