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
FDA Recalls Bi-Mix Phentolamine/Papaverine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Bi-Mix Phentolamine/Papaverine injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Product
BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 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
HighFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Sermorelin Acetate Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Sermorelin Acetate 10 mg injectable because FDA inspectional findings raised concerns about sterility assurance and quality control.
Product
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
Category
Distribution
0 states
SevereFDA (Drugs)··2013-09-18
FDA Recalls Compounded HCG Vials Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling compounded HCG vials because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS 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 Triple-Testosterone Injections Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Triple-Testosterone oil injection solutions because FDA inspections raised concerns about quality control and sterility assurance.
Product
TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, 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 DMSO 50% Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling DMSO 50% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
DMSO 50% INJ 50 ML VIAL 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 Alprostadil Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Alprostadil injection due to FDA inspectional findings regarding quality control and sterility assurance.
Product
ALPROSTADIL, 50 MCG/ML 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
Category
Distribution
0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Selenium Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Selenium 400 mcg/mL injectable because FDA inspections raised concerns about quality control and sterility assurance.
Product
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
Category
Distribution
0 states
HighFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Methylcobalamin injections because FDA inspections found quality control issues that impacted sterility assurance.
Product
METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML 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 Ascorbic Acid Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Ascorbic Acid 500 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
Product
ASCORBIC ACID ( non-CORN SOURCE) 500 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
Beacon Hill Medical Pharmacy Recalls Pyridoxine HCL Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Pyridoxine HCL Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Testosterone Propionate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Testosterone Propionate 100 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.
Product
TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, 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