Class III · Low risk Terminated
HydrOXYzine Hydrochloride Oral Solution
Reason Subpotent; 24 month stability test station
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Amoxicillin for Oral Suspension
Reason Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Class III · Low risk Terminated
Lamisil AT
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class III · Low risk Terminated
Lisinopril Tablets
Reason Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Class III · Low risk Terminated
Bucalsep
Reason Subpotent; Cetylpyridinum Chloride
Class III · Low risk Terminated
Glenmark Topiramate Tablets
Reason Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Class III · Low risk Terminated
Glenmark Pravastatin Sodium Tablets
Reason Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Class III · Low risk Terminated
Glenmark Gabapentin Tablets
Reason Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
Class III · Low risk Terminated
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk Terminated
Lorazepam
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets
Reason Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk Terminated
Disulfiram Tablets USP 250 mg
Reason CGMP Deviation; cotton coil is missing in some packaged bottles
Class III · Low risk Terminated
Tizanidine Tablets USP
Reason Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Class III · Low risk Terminated
Camila 0.35 mg Tablets
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Oxcarbazepine Tablets
Reason SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Class III · Low risk Terminated
Cherry Cepacol Sore Throat Lozenges
Reason Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Class III · Low risk Terminated
Camila
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Errin
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Balziva
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Jolessa
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Junel
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Lessina
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Camrese
Reason Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk Terminated
Seasonale
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications: 3 month stability testing.