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the Compounder

FDA Regulatory Profile

Summary

Total Recalls
47
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0225-2016Class IIESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (March 10, 2015
D-0226-2016Class IITRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdMarch 10, 2015
D-0207-2016Class IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) March 10, 2015
D-0196-2016Class IIBIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP March 10, 2015
D-0203-2016Class IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP MMarch 10, 2015
D-0205-2016Class IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP MiMarch 10, 2015
D-0195-2016Class IIBIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977]March 10, 2015
D-0212-2016Class IIBIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/March 10, 2015
D-0209-2016Class IIBIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MGMarch 10, 2015
D-0188-2016Class IIBIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 March 10, 2015
D-0192-2016Class IIBIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5March 10, 2015
D-0211-2016Class IIBIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABAMarch 10, 2015
D-0214-2016Class IIESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 605March 10, 2015
D-0199-2016Class IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP MiMarch 10, 2015
D-0222-2016Class IIESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefillMarch 10, 2015
D-0185-2016Class IIBIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only,March 10, 2015
D-0228-2016Class IITRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx onMarch 10, 2015
D-0194-2016Class IIBIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/March 10, 2015
D-0186-2016Class IIBIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, March 10, 2015
D-0215-2016Class IIESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASMarch 10, 2015