Class III · Low risk Terminated
Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30…
Reason Failed Dissolution Specifications
Is Estrogens recalled?
9 FDA recalls mention Estrogens. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Estrogens.
Class III · Low risk Terminated
Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal…
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk Terminated
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal…
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class II · Moderate risk Terminated
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho…
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk Terminated
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By…
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk Terminated
ESTERIFIED ESTROGENS Tablet, 0.625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61570007301
Reason Labeling:Label Mixup; ESTERIFIED ESTROGENS, Tablet, 0.625 mg may be potentially mislabeled as ETODOLAC, Tablet, 400 mg, NDC 51672401801, Pedigree…
Class III · Low risk Terminated
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed…
Reason Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk Terminated
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva…
Reason Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk Terminated
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed…
Reason Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
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