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.
Reported: June 14, 2017 Initiated: April 13, 2017 #D-0882-2017
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.
Details
- Recalling Firm
- Spectrum Laboratory Products, Inc.
- Units Affected
- 1 container
- Distribution
- Nationwide in the USA
- Location
- New Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spectrum Laboratory Products, Inc.. Units affected: 1 container.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 14, 2017. Severity: Moderate. Recall number: D-0882-2017.
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