Class II · Moderate risk
CITALOPRAM Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Citalopram Oral Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
0121-1696-40
Compare with the code on your package — it is the most precise check available.
Drug: Citalopram Category: Mental Health Medication
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- NDC code
- 0121-1696-40
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0015-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Citalopram recalls
See all
Class II · Moderate risk
All citalopram Products
Lack of Processing Controls
Class II · Moderate risk
Citalopram Hydrobromide active pharmaceutical ingredient packaged…
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.
Class II · Moderate risk
CITALOPRAM Tablet
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.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Other recalls by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
All 2020 recalls
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
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