Class I · High risk
SYMJEPI (epinephrine injection, USP)
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
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 I · High risk
SYMJEPI (epinephrine injection, USP)
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class II · Moderate risk
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Class II · Moderate risk
Brinzolamide Ophthalmic Suspension
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class II · Moderate risk
Diclofenac Sodium Topical Solution 1.5%
Defective Container: Leaking containers.
Class II · Moderate risk
Diclofenac Sodium Topical Solution
Defective container: Out of specification for container integrity leading to bottles leaking.
Class II · Moderate risk
Hand Sanitizer Foam
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class II · Moderate risk
Morphine Sulfate Injection
Defective container: Cracked vials leading to lack of sterility assurance
Class II · Moderate risk
Erythromycin Topical Solution USP
Defective container: possibility for lack of seal integrity.
Class I · High risk
Prairie Wolf Distillery Alcohol Antiseptic 80%
Hand sanitizer packaged in bottles that resemble beverage containers.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class I · High risk
BD ChloraPrep Hi-Lite Orange 26 mL Applicator
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class III · Low risk
Evrysdi (risdiplam)
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Class II · Moderate risk
Estradiol Transdermal System Delivers 0.0375 mg/day
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
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