CITALOPRAM Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
CITALOPRAM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050788
Compare with the code on your package — it is the most precise check available.
Drug: Citalopram Category: Mental Health Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Lack of Processing Controls
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.
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014.
Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD21790_28, EXP: 5/1/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W002730, EXP: 6/6/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: W003680, EXP: 6/25/2014; VENLAFAXINE HCL
Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree: AD52778_88, EXP: 5/21/2014.
Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014; QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24/2014; POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, NDC 00486111101, Pedigree: AD52778_34, EXP: 5/20/2
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