Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect or Missing Lot and/or Expiration Date
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
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: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Reason Lack of Processing Controls
Reason Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged…
Reason Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC…
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