Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
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.
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.
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
Subpotent Drug: Drug potency was compromised during shipment.
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.