64 FDA recalls mention Ethinyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ethinyl.
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Reason Failed Impurities/Degradation Specifications
Reason Failed Content Uniformity Specifications
Reason Failed Dissolution Specifications
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Subpotent Drug
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Reason CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Reason Failed dissolution specifications : failed results at the 3-month stability time point.
Reason Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and…
Reason Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Reason Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Reason Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Reason Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Reason Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on…
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