Class III · Low risk
Budesonide Capsules
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
FDA Drug Recalls
170 recalls · Class III, newest first
Class III · Low risk
Nicardipine Hydrochloride Injection 25 mg/10 mL
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Class III · Low risk
Derma-Smoothe/FS
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
HydrOXYzine Hydrochloride Oral Solution
Subpotent; 24 month stability test station
Class III · Low risk
Amoxicillin for Oral Suspension
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
Lamisil AT
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
Lisinopril Tablets
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Class III · Low risk
Bucalsep
Subpotent; Cetylpyridinum Chloride
Class III · Low risk
Glenmark Topiramate Tablets
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
Glenmark Pravastatin Sodium Tablets
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
Glenmark Gabapentin Tablets
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
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF
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
Lorazepam
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
Disulfiram Tablets USP 250 mg
CGMP Deviation; cotton coil is missing in some packaged bottles
Class III · Low risk
Tizanidine Tablets USP
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
Camila 0.35 mg Tablets
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Oxcarbazepine Tablets
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
Cherry Cepacol Sore Throat Lozenges
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Class III · Low risk
Camila (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Errin (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Balziva (norethindrone and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Junel
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Lessina (Levonorgestrel and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing