Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
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: Released product should have been rejected.
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Reason Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Reason Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the…
Reason Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly…
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