US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Betamethasone SP

Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

US Compounding Inc NDC 62295-3240-07 D-0240-2016
Class II · Moderate risk Terminated

Betamethasone Combo PF 2 mL

Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

US Compounding Inc NDC 62295-3018-02 D-0239-2016
Class II · Moderate risk Terminated

Betamethasone Combo 10 mL

Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

US Compounding Inc NDC 62295-3018-10 D-0238-2016
Class II · Moderate risk Terminated

Alprostadil

Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

US Compounding Inc D-0237-2016
Class II · Moderate risk Terminated

Acetylcysteine 10% Ophtalmic

Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

US Compounding Inc D-0236-2016
Class II · Moderate risk Terminated

Surgicept

Reason Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.

Healthpoint, Ltd D-1427-2015
Class II · Moderate risk Terminated

Fenoglide

Reason Failed Dissolution Specifications: Failed 24 month dissolution testing.

Valeant Pharmaceuticals North America LLC D-0163-2016
Class II · Moderate risk Terminated

Trimix Special

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-336-2016
Class II · Moderate risk Terminated

Trimix #4

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-335-2016
Class II · Moderate risk Terminated

Trimix #3

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-334-2016
Class II · Moderate risk Terminated

Trimix #2

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-333-2016
Class II · Moderate risk Terminated

TRIMIX #1 Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-332-2016
Class II · Moderate risk Terminated

Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-331-2016
Class II · Moderate risk Terminated

Testosterone CYP/ENAN/PROP Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-330-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 200 mcg/mL in Corn Oil Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-329-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-328-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 50 mg/mL Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-327-2016
Class II · Moderate risk Terminated

sermorelin 1000 mcg/mL / LIDO 0.2% Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-326-2016
Class II · Moderate risk Terminated

Sermorelin 1000 mcg/mL SUB-Q* Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-325-2016
Class II · Moderate risk Terminated

Sermorelin 9 mg/10 mL SUB-Q* Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-324-2016
Class II · Moderate risk Terminated

Quad Mix

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-323-2016
Class II · Moderate risk Terminated

Progesterone 100 mg/mL Ethyl Oleate Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-322-2016
Class II · Moderate risk Terminated

Progesterone 100 mg/mL in Corn Oil Injection

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-321-2016
Class II · Moderate risk Terminated

Progesterone 100 mg/mL IM* Injection in Sesame Oil

Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-320-2016