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 Hydroxyprogesterone recalled?
34 FDA recalls mention Hydroxyprogesterone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxyprogesterone.
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
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
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
hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy…
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of…
Class II · Moderate risk Terminated
hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy…
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of…
Class II · Moderate risk Terminated
17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N…
Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with…
Class II · Moderate risk Terminated
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N…
Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with…
Class II · Moderate risk Terminated
HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL…
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk Terminated
17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box…
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room Temperature, The Compounding Pharmacy of…
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate, 250 mg per mL, 5 mL vial, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Reason Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the…
Class II · Moderate risk Terminated
HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Class II · Moderate risk Terminated
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty…
Reason Crystallization: Formation of crystals observed in product.
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient…
Reason Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
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