Class II · Moderate risk Ongoing
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Is Estradiol recalled?
296 FDA recalls mention Estradiol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Estradiol.
Class II · Moderate risk Terminated
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk Terminated
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured…
Reason Mislabeling
Class III · Low risk Terminated
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured…
Reason Mislabeling
Class III · Low risk Terminated
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets…
Reason Subpotent Drug
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Ongoing
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC…
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Ongoing
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems…
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Terminated
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida…
Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the…
Class II · Moderate risk Terminated
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc…
Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the…
Class II · Moderate risk Terminated
Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx…
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class II · Moderate risk Terminated
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c)…
Reason cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Class II · Moderate risk Terminated
Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Reason Lack of Processing Control
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