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.

1–25 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 Monobasic/Water for Injection 10% because FDA inspections raised concerns about sterility assurance and quality control.
Product
SODIUM PHOSPHATE MONOBASIC/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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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls B-12 Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-12 Rejuv 25 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
Product
B-12 REJUV 25 MG/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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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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Potassium Chloride 2 mEq/mL Injectable because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.
Product
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
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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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Multitrace-5 Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Multitrace-5 Injectable because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Furosemide Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Furosemide 10 mg/mL injectable products because FDA inspectional findings raised concerns about sterility assurance.
Product
FUROSEMIDE 10 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 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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls PUMICE/LIDOCAINE HCL Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling PUMICE/LIDOCAINE HCL 1.5%/1% Injection Suspensions because FDA inspections raised concerns about sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Freamine III Alt 8.5% Injectable
Beacon Hill Medical Pharmacy is recalling Freamine III Alt 8.5% Injectable due to sterility assurance concerns identified during an FDA inspection.
Product
FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
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0 states
SevereFDA (Drugs)··2013-09-18
FDA Recalls Chromium Injectable Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling Chromium 4 mcg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Product
CHROMIUM 4 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
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0 states
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Lipo-Plex Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Lipo-Plex Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
LIPO-PLEX 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 Compounded Progesterone/Testosterone Injection
Beacon Hill Medical Pharmacy is recalling compounded progesterone and testosterone injections due to FDA inspectional findings regarding sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls B-Complex Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-Complex/Lido/B-12 injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Product
B-COMPLEX/LIDO/B-12, 25MG/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 Cyanocobalamin Injections Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded cyanocobalamin injections because FDA inspections raised concerns about sterility assurance and quality control.
Product
CYANOCOBALAMIN 1000 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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Arginine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Arginine (R-Gene) 100 mg/mL injectable because FDA inspectional findings raised concerns about sterility assurance.
Product
ARGININE (R-GENE) 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 Estradiol Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding sterility assurance.
Product
ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 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
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded sterile injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.
Product
GLUTATHIONE/LIDO 100MG/2%/ML (PF) 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
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Glutathione Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Glutathione 200 mg/mL injection solution because FDA inspections raised concerns about sterility assurance and quality control.
Product
GLUTATHIONE 200 MG/ML (PF) 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
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Oxytocin Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Oxytocin 10 Units/mL because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Triamcinolone Acetonide Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded Triamcinolone Acetonide injections because FDA inspections raised concerns about sterility assurance.
Product
TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, 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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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Zinc Sulfate Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Zinc Sulfate 1 mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
Zinc Sulfate 1 mg/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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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Quad Amino Blend Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Quad Amino Blend 150/75/150/75 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Product
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
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0 states