FDA Recall
Terminated
Historical recordClass II
Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
by Leiter's Pharmacy
- Reason
- Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
- Published
- September 25, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
by Leiter's Pharmacy
- Reason
- Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
- Published
- September 25, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
by Beacon Hill Medical Pharmacy, P.C.
- Reason
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Published
- September 18, 2013
- 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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