Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
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
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Daytrana (methylphenidate)
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Class II · Moderate risk
Daytrana (methylphenidate)
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Class II · Moderate risk
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Class II · Moderate risk
GREENSTONE BRAND fluconazole for Oral Suspension
Defective Container: Tamper evident ring failures discovered on some bottles.
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Class II · Moderate risk
Acetaminophen suspension liquid
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Class II · Moderate risk
Phenytoin Oral Suspension USP 125mg/5mL
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Class II · Moderate risk
DIANEAL Low Calcium
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Class III · Low risk
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Class II · Moderate risk
Parsel Plus
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
No Doz
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Migraine
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Extra Strength
Defective container: products are packaged in pouches which may not have been fully sealed
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