Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Lack of Assurance of Sterility
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