Is Benzocaine recalled?
36 FDA recalls mention Benzocaine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzocaine.
Class III · Low risk Terminated Apr 25, 2019
Reason Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class II · Moderate risk Terminated Nov 16, 2018
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated Aug 3, 2018
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated Nov 16, 2017
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated Nov 16, 2017
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated Mar 25, 2016
Reason Lack of Processing Controls
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060…
Class III · Low risk Terminated Apr 8, 2013
Reason Subpotent; Cetylpyridinum Chloride
Class III · Low risk Terminated Mar 18, 2013
Reason Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Class II · Moderate risk Terminated May 9, 2012
Reason Superpotent; benzocaine