Class III · Low risk Terminated
North by Honeywell PAIN STOPPER EXTRA STRENGTH
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
AERO Tab PAIN RELIEVER
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
ZEE+ painaid ESF Extra-Strength Formula
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Vica-Cet BACK PAIN RELIEF
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
PainAway II
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
AllerClear D-24 hr
Reason Failed Moisture Limits
Class III · Low risk Terminated
Loratadine-D Extended-Release Tablets
Reason Failed Moisture Limits
Class III · Low risk Terminated
Cetirizine hydrochloride
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 tablets.
Class III · Low risk Ongoing
Butalbital
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk Ongoing
Butalbital
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; out of specification for Related Compound
Class III · Low risk Terminated
Glycopyrrolate Injection
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials…
Reason Subpotent Drug
Class III · Low risk Terminated
Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ
Reason Subpotent Drug
Class III · Low risk Terminated
Hydroquinone
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
Class III · Low risk Terminated
Sodium Sulfacetamide
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
Class III · Low risk Terminated
Donepezil HCL Tablets
Reason Subpotent
Class III · Low risk Terminated
Bleomycin for Injection
Reason Labeling: Not elsewhere classified: Mislabeling
Class III · Low risk Terminated
Avicel
Reason Out of specification results for conductivity.
Class III · Low risk Terminated
Lidocaine Ointment USP
Reason Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class III · Low risk Terminated
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Reason Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class III · Low risk Terminated
Leukine
Reason FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Class III · Low risk Terminated
Erythromycin Topical Gel
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Erythromycin Topical Solution USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
B-Force
Reason Superpotent