Class II · Moderate risk
Scopolamine Transdermal Therapeutic System
Defective delivery system
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
Minivelle (estradiol transdermal system)
Defective Delivery System: no longer meets the specification for 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: no longer meets the specification for 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
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for adhesive transfer.
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Class II · Moderate risk
Evamist (estradiol transdermal spray)
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Class II · Moderate risk
Labetalol Hydrochloride Injection
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Class II · Moderate risk
VELCADE (bortezomib)
Defective Container: Confirmed reports of loose vial crimps.
Class III · Low risk
Ultane (sevoflurane)
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Class II · Moderate risk
Neutrogena Elevated 4-Holiday Trays
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Neutrogena deep clean purifying whipped foam cleanser
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Neutrogena Acne Proofing whipped foam cleanser
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class I · High risk
Lorazepam Oral Concentrate
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Class II · Moderate risk
Morphine Sulfate Oral Solution
Defective container: Oral solution leaking from container.
Class II · Moderate risk
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Class II · Moderate risk
Option 2
Defective Container: Carton is missing the tablet blister strip and tablet.
Class II · Moderate risk
Levophed norepinephrine bitartrate
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Class III · Low risk
Minivelle (estradiol Transdermal System)
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class II · Moderate risk
Alka-Seltzer Gold
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk
Alka-Seltzer Extra Strength
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
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