30 FDA recalls mention Cetirizine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cetirizine.
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
Reason Tablet/Capsules Imprinted with Wrong ID
Reason Tablet/Capsules Imprinted with Wrong ID
Reason CGMP Deviations
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have…
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have…
Reason cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Reason Lack of Processing Controls
Reason Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Reason Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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