FDA Recall
Terminated
Historical recordClass II
Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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