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.

51–75 of 86

SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Magnesium Sulfate Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Sulfate 50% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
MAGNESIUM SULFATE 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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0 states
SevereFDA (Drugs)··2013-09-18
FDA Recalls Naltrexone Injectable Due to Sterility Assurance Concerns
The FDA is recalling Naltrexone 1 mg/mL and 200 mg/mL injectables compounded by Beacon Hill Medical Pharmacy due to quality control issues affecting sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Glycine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Glycine 50 mg/mL injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Product
GLYCINE 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
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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 products due to FDA inspectional findings regarding sterility assurance.
Product
ASCORBIC ACID (CORN SOURCE) 500 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 Vitamin B-Complex Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Vitamin B-Complex Injectable products because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) 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 Dexpantenol Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Dexpantenol 250 mg/mL injectable products because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
DEXPANTHENOL 250 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 Dual-Testosterone Injections for Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Dual-Testosterone oil injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.
Product
DUAL-TESTOSTERONE 20, 50, 100, 150, 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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls MIC-CARN MAX Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling MIC-CARN MAX injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
MIC-CARN MAX 15/100/50/1 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 Estradiol Cypionate Injections for Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded estradiol cypionate injections due to FDA inspectional findings regarding quality control and sterility assurance.
Product
ESTRADIOL CYPIONATE 5, 10, 40 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
SevereFDA (Drugs)··2013-09-18
Sodium Bicarbonate Injectable Recalled for Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling Sodium Bicarbonate PF 8.4% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Magnesium Chloride Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Chloride Hexahydrate 20% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
MAGNESIUM CHLORIDE HEXAHYDRATE 20% 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 Glycyrrhizic Acid Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Glycyrrhizic Acid 8 mg/mL Injectable because FDA inspectional findings raised concerns about sterility assurance.
Product
GLYCYRRHIZIC ACID 8 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 Parabens Water for Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling all presentations of Parabens Water for Injection because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Product
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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Calcium EDTA Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 200 mg/mL injectable products because FDA inspectional findings raised concerns about quality control and sterility assurance.
Product
CALCIUM EDTA 200 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 Calcium Chloride Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Calcium Chloride 100 mg/mL Injectable because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Product
CALCIUM CHLORIDE 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 Methylprednisolone Acetate Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Methylprednisolone Acetate injectable products because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Product
METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 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 Lidocaine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Lidocaine MDV and Lidocaine PF injectables because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Product
LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 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
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0 states
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Acetylcysteine Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Acetylcysteine 100 mg/mL injection solution because FDA inspectional findings raised concerns about quality control and sterility assurance.
Product
ACETYLCYSTEINE 100 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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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
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Testosterone Cypionate Injections for Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded testosterone cypionate injections due to FDA inspectional findings regarding sterility assurance and quality control.
Product
TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 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
SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Estriol Oil Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Estriol 5 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.
Product
ESTRIOL 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
FDA Recalls Testosterone Injectable Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling Testosterone Hypoallergenic and Testosterone Aqueous injectables due to FDA inspectional findings regarding sterility assurance.
Product
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 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 Manganese Sulfate Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Manganese Sulfate 0.1 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Product
MANGANESE SULFATE 0.1 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
FDA Recalls Compounded Injectable Solution Due to Sterility Assurance Concerns
Beacon Hill Medical Pharmacy is recalling compounded glutathione/methyl/lido injectable solutions because FDA inspections raised concerns about sterility assurance.
Product
GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/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
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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0 states