23 FDA recalls mention Levonorgestrel. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Levonorgestrel.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and…
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 Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Reason Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Reason Defective Container: Carton is missing the tablet blister strip and tablet.
Reason CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient…
Reason cGMP Deviations; lack of quality assurance.
Reason Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package…
Reason Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Reason Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP…
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Reason Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Reason Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Reason Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Reason Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated…
Reason Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
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