Class II · Moderate risk
Vitamin D3
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
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
Xelstrym (dextroamphetamine)
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class III · Low risk
Ciclopirox Gel 0.77%
Defective Container: Firm received complaints of broken tube at the seal.
Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class III · Low risk
Varithena (polidocanol injectable foam)
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk
Ciprofloxacin ophthalmic solution USP
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective container; yellow colored spike from cap lodged in the nozzle
Class III · Low risk
Peg-3350
Defective container: potential for non-sealed pouches which can lead to product leakage.
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Defective container: lack of seal integrity.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class III · Low risk
Clindamycin Phosphate
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class I · High risk
Vigabatrin for Oral Solution
Defective Container: powder may leak out of the pouch
Class III · Low risk
Mycophenolate Mofetil for Oral Suspension
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Defective Container: slow leakage under the cap
Class I · High risk
Albuterol Sulfate Inhalation Aerosol
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Delivery System
Class II · Moderate risk
Tramadol Hydrochloride Tablets
Packaging defect: blister packaging inadequately sealed.
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