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.

Mar 15, 2019 Class III · Low risk

Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15

Defective container: Ineffective seal between the cap and jar of the affected product.

Terminated Packaging defect Estee Lauder Inc D-1132-2019

Mar 13, 2019 Class III · Low risk

Testosterone Topical Solution

Defective Container: Repetitive complaints received indicating pump not working.

Terminated Packaging defect Lupin Pharmaceuticals Inc. NDC 68180-943-11 D-1010-2019

Mar 6, 2019 Class II · Moderate risk

Docetaxel Injection USP

Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.

Terminated Packaging defect Dr. Reddy's Laboratories, Inc. NDC 43598-259-40 D-1001-2019

Feb 1, 2019 Class II · Moderate risk

Dymista (azelastine hydrochloride and fluticasone propionate)

Defective Container: Potential for broken glass in the neck area of the glass bottles.

Terminated Packaging defect Mylan Pharmaceuticals Inc. NDC 0037-0245-23 D-0424-2019

Jan 11, 2019 Class III · Low risk

Clobetasol Propionate Topical Solution USP

Defective Container; complaints of leakage.

Terminated Packaging defect Oxalis Labs NDC 33342-321-86 D-0492-2019

Jan 9, 2019 Class II · Moderate risk

Cephalexin for Oral Suspension USP 250mg/5 mL

CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

Terminated Packaging defect Lupin Pharmaceuticals Inc. NDC 68180-441-01 D-0423-2019

Dec 26, 2018 Class II · Moderate risk

Estradiol Vaginal Inserts

Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator

Terminated Packaging defect Glenmark Pharmaceuticals Inc., USA NDC 68462-711-71 D-0350-2019

Oct 29, 2018 Class II · Moderate risk

Omnipaque (iohexol)

Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.

Terminated Packaging defect GE Healthcare Inc. Life Sciences NDC 0407-1411-20 D-0319-2019

Oct 9, 2018 Class III · Low risk

Testosterone Topical Solution

Defective Container: Repetitive complaints received indicating pump not working.

Terminated Packaging defect Lupin Pharmaceuticals Inc. NDC 68180-943-11 D-0087-2019

Oct 5, 2018 Class III · Low risk

Contrave (naltrexone HCl and bupropion HCl)

Container packaging defect.

Terminated Packaging defect Orexigen Therapeutics, Inc. NDC 51267-890-99 D-0219-2019

Sep 10, 2018 Class II · Moderate risk

Actoplus met XR

Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.

Terminated Packaging defect Takeda Development Center Americas, Inc. D-0026-2019

Sep 7, 2018 Class II · Moderate risk

Minivelle (estradiol transdermal system)

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-6675-8 D-1210-2018

Sep 7, 2018 Class II · Moderate risk

Minivelle (estradiol transdermal system)

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-6625-8 D-1209-2018

Sep 7, 2018 Class II · Moderate risk

Minivelle (estradiol transdermal system)

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-6650-8 D-1208-2018

Sep 7, 2018 Class II · Moderate risk

Minivelle (estradiol transdermal system)

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 68968-6610-8 D-1207-2018

Aug 14, 2018 Class III · Low risk

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

Terminated Packaging defect United Therapeutics Corp. NDC 66302-206-01 D-1188-2018

Aug 9, 2018 Class III · Low risk

Contrave (naltrexone HCl and bupropion HCl)

Defective Container: Customer complaints of punctures in the bottle.

Terminated Packaging defect Orexigen Therapeutics, Inc. NDC 51267-890-99 D-1099-2018

Aug 6, 2018 Class II · Moderate risk