Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Packaging & closure defects
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination.
318 FDA drug recalls with this cause, newest first.
These recalls involve the container rather than the contents - failed child-resistant closures, leaking bags or vials, cracked cartridges, blister packs with holes, or a delivery device (pump, applicator, syringe) that does not work as designed. A seal problem can let contamination in after the product leaves the factory, and a failed child-resistant cap puts children at risk of accidental exposure.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk
Susvimo (ranibizumab injection)
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class III · Low risk
Zynrelef (bupivacaine and meloxicam)
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class II · Moderate risk
PrednisoLONE Oral Solution USP
Defective Container: Product has incomplete induction seals.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP - Water leakage
Class III · Low risk
Mometasone Furoate
Defective Container
Class II · Moderate risk
70% ISOPROPYL ALCOHOL First aid antiseptic
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Calcipotriene Topical Solution
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: customer complaints exceeded respective action limits.
Class II · Moderate risk
MVASI (bevacizumab-awwb)
Defective container: loose crimp defect, potential loss of container integrity.
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