Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
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 Lack of Processing Controls
Reason Labeling: Incorrect or Missing Lot and/or Expiration Date
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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