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.

26–50 of 86

SevereFDA (Drugs)··2013-09-18
Beacon Hill Medical Pharmacy Recalls Compounded Nandrolone Decanoate Injections
Beacon Hill Medical Pharmacy is recalling compounded Nandrolone Decanoate injections due to FDA inspectional findings regarding sterility assurance.
Product
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
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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 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 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
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 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 Compounded Buprenorphine Cream
Beacon Hill Medical Pharmacy is recalling compounded buprenorphine cream due to sterility assurance concerns identified during an FDA inspection.
Product
BUPRENORPHINE 0.1/0.05 MG/ML CREAM, 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 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
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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
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
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 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 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 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 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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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 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
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
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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0 states
SevereFDA (Drugs)··2013-09-18
FDA Recalls Bi-Tropin S-2 Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Bi-Tropin S-2 Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
BI-TROPIN S-2 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 Lipolic Acid Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Lipolic Acid injectable products because FDA inspections raised concerns about sterility assurance and quality control.
Product
LIPOIC ACID 100 MG/ML 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 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 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 Nalbuphine HCL Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Nalbuphine HCL 20 mg/mL injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
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
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0 states