Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE…
Reason Lack of Assurance of Sterility
Is Progesterone recalled?
171 FDA recalls mention Progesterone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Progesterone.
Class II · Moderate risk Terminated
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Progesterone E4M SR 100 mg capsules
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Progesterone 50 mg capsules
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Progesterone 200 mg Troche
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J…
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy…
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW…
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd…
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro…
Reason Lack of Processing Controls.
Class III · Low risk Terminated
Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122…
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122…
Reason Labeling Not Elsewhere Classified: Misbranding.
Class II · Moderate risk Terminated
Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A…
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV…
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6)…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class II · Moderate risk Terminated
Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141…
Reason Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the…
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