Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Physicians Total Care, Inc.

NDC code

54868-6165-1

Origin

OK, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-092-2013

Other Estrogens recalls

See all

Class III · Low risk Terminated May 27, 2020

Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30…

Reason Failed Dissolution Specifications

Pfizer Inc. NDC 00008-1123-12 D-1342-2020

Class III · Low risk Terminated Sep 25, 2017

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.

Amneal Pharmaceuticals, Inc. NDC 13925-172-01 D-1439-2019

Class III · Low risk Terminated Sep 25, 2017

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.

Amneal Pharmaceuticals, Inc. NDC 13925-171-01 D-1438-2019

Class II · Moderate risk Terminated Apr 17, 2017

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.

Syntho Pharmaceuticals, Inc. NDC 15310-010-01 D-0378-2019

Class II · Moderate risk Terminated Apr 17, 2017

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.

Syntho Pharmaceuticals, Inc. NDC 15310-020-01 D-0377-2019