FDA (Drugs) recall action 65876

Beacon Hill Medical Pharmacy, P.C. recalled 86 products on 2013-09-18

The FDA (Drugs) publishes a recall like this one as 86 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 86 pages.

Products: 86
Announced: 2013-09-18
Critical: 0
Units: —

Why these products were recalled

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.

The agency’s own wording, quoted from the enforcement report.

76–86 of 86

SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Sodium Phosphate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Dibasic/Water for Injection 10% because FDA inspections raised concerns about quality control and sterility assurance.
Product
SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
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Distribution
0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Hyaluronidase Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Hyaluronidase 150 U/ML and 200 U/ML Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
HYALURONIDASE 150 U/ML and 200 U/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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Progesterone Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling progesterone 50 mg/mL oil injection solution because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.
Product
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
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Distribution
0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls EDETATE DISODIUM INJECTABLE Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling EDETATE DISODIUM 150 MG/ML INJECTABLE because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Product
EDETATE DISODIUM 150 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
Category
Distribution
0 states
SevereFDA (Drugs)··2013-09-18
FDA Recalls Triptropin Plus Injectable Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling Triptropin Plus Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
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Distribution
0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Vitamin D Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Vitamin D 50,000 I.U./ML Injectable due to FDA inspectional findings regarding sterility assurance and quality control.
Product
VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
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Distribution
0 states
SevereFDA (Drugs)··2013-09-18
FDA Recalls Phosphatidylcholine Injectable Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling Phosphatidylcholine 50 mg/mL Injectable because FDA inspections raised concerns about quality control and sterility assurance.
Product
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
Category
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Dextrose PF 50% Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Dextrose PF 50% Injectable because FDA inspections raised concerns about quality control and sterility assurance.
Product
DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
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Distribution
0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Alprostadil 100 mcg/mL injection solution because FDA inspections raised concerns about quality control and sterility assurance.
Product
ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Category
Distribution
0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Hydroxocobalamin Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Hydroxocobalamin (Vitamin B12A) 1 mg/mL injectable products due to FDA inspectional findings regarding quality control and sterility assurance.
Product
HYDROXOCOBALAMIN (VITAMIN B12A) 1 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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Hydroxyprogesterone Caproate Injection
Beacon Hill Medical Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to sterility assurance concerns identified during an FDA inspection.
Product
HYDROXYPROGESTERONE CAPROATE 250 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
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0 states