Class II · Moderate risk Terminated
CITALOPRAM Tablets
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CITALOPRAM Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling:Label Mixup; CITALOPRAM Tablet, 10 mg may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 5 mg, NDC 00603497521, Pedigree: AD52778_61, EXP: 5/20/2014; COENZYME Q-10, Capsule, 30 mg, NDC 00904501546, Pedigree: W002814, EXP: 6/7/2014.
What was recalled
CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050788
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-630-2014
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.
Other Citalopram recalls
See all
Class III · Low risk Terminated
Citalopram Oral Solution
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Class II · Moderate risk Terminated
All citalopram Products
Reason Lack of Processing Controls
Class III · Low risk Terminated
Escitalopram Tablets USP 20 mg
Reason Labeling: Incorrect or Missing Lot and/or Expiration Date
Class II · Moderate risk Terminated
Citalopram Hydrobromide active pharmaceutical ingredient packaged…
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 in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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