September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical: 15
Severe: 203
High: 216
Moderate: 81
Low: 15

Of the 530 recalls this month scored against our rubric, 3% are Critical, 38% are Severe.

Which agencies issued them

201–300 of 530

SevereFDA (Drugs)·D-991-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-985-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2119-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-981-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-933-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-969-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1033-2013·2013-09-18
Wellness Pharmacy Recalls Phenylbutyrate Due to Sterility Concerns
Wellness Pharmacy is recalling Phenylbutyrate 200 mg/mL vials because laboratory results indicate microbial contamination and the FDA has concerns about the reliability of the testing data.
Product
NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1019-2013·2013-09-18
FDA Recalls Glutathione Injectable Due to Potential Bacterial Contamination
Creative Compounds is recalling 16 vials of Glutathione 100 mg/mL Injectable due to out-of-specification results and potential bacterial contamination.
Product
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-970-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1025-2013·2013-09-18
Park Compounding Recalls Methylcobalamin Injection Due to Sterility Concerns
South Coast Specialty Compounding is recalling Methylcobalamin Injection 5 mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in California and Indiana.
Product
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1028-2013·2013-09-18
Pharmacy Creations Recalls Lidocaine Injection Due to Sterility Concerns
Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection vials because the company cannot guarantee the product is sterile.
Product
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-948-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-968-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1015-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-988-2013·2013-09-18
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
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2121-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads
Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-955-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-944-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V439000·2013-09-18
Navistar Recalls 2008-2013 International Trucks Due to Air Line Assembly Error
Navistar is recalling 2008-2013 International LoneStar, ProStar, and TranStar trucks because an assembly error in the air lines may cause the fifth wheel jaw to release unexpectedly, increasing crash risk.
Product
INTERNATIONAL — INTERNATIONAL TRANSTAR, LONESTAR, PROSTAR
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-946-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-965-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2120-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
Product
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-986-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-938-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2122-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2184-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water. The products are distributed in the USA and Bermuda.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1000-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V453000·2013-09-18
Spartan Motors Recalls Transit Bus Chassis Cabs Due to Sway Bar Fastener Issue
Spartan Motors is recalling 2011-2013 Transit Bus Chassis Cabs because front sway bar fasteners may loosen, potentially damaging brake lines and increasing crash risk.
Product
SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-979-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-936-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-963-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1020-2013·2013-09-18
University Compounding Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns
University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate Injection due to lack of assurance of sterility. The recall affects 178.2 mL of the product nationwide.
Product
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-992-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V468000·2013-09-18
2013 Thomas Built Minotour School Bus Floor Bond Recall
Daimler Trucks North America is recalling 2013 Thomas Built Minotour school buses because floor sheet metal may not be properly bonded, increasing injury risk in a crash.
Product
THOMAS BUILT — THOMAS BUILT MINOTOUR
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-942-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1993-2013·2013-09-18
Cardiogenesis Transmyocardial Laser Recalled Due to Sparks and Burns
Cardiogenesis Corporation is recalling 2,498 Transmyocardial Laser devices due to reports of sparks, burns, or smoke incidents.
Product
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery…
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-975-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-993-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1001-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-983-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1016-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1006-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1017-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Calcium EDTA Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 300 mg/mL Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Product
CALCIUM EDTA 300 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1013-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1003-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-971-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Ketorolac Tromethamine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Ketorolac Tromethamine 60 mg/mL injectable because FDA inspectional findings raised concerns about quality control and sterility assurance.
Product
KETOROLAC TROMETHAMINE 60 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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-952-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-956-2013·2013-09-18
FDA Recalls Estradiol Valerate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Estradiol Valerate with Lidocaine injection because FDA inspections raised concerns about sterility assurance.
Product
ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-945-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Copper Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Copper 0.4mg/mL Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
COPPER 0.4MG/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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1009-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2180-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
Covidien LLC is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-947-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable
Beacon Hill Medical Pharmacy is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable due to sterility assurance concerns identified during an FDA inspection.
Product
DEXAMETHASONE SODIUM PHOSPHATE 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1027-2013·2013-09-18
Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance
South Coast Specialty Compounding is voluntarily recalling Testosterone Cypionate injections due to a lack of sterility assurance.
Product
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1014-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2185-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA Class II recall of Monoject 100 Units/mL Heparin Lock Flush syringes due to potential non-sterile water contamination.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1878-2013·2013-09-18
Bubbles Baking Co. Recalls Coffee Cake Muffins for Undeclared Pecans
Bubbles Baking Co. is recalling First Street Coffee Cake Muffins because they may contain undeclared pecan nuts. The recall covers 8,478 units distributed in California, Nevada, and Arizona.
Product
First Street Coffee Cake Muffins (S 45398) 4 count 14 oz. UPC 0 4151210848 8
Category
Food
Distribution
3 states
SevereFDA (Drugs)·D-940-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Compounded Injectable Solution Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling compounded B12/E2/E3/PROG/TEST injectable solution due to FDA inspectional findings regarding sterility assurance.
Product
B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-980-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls MIC-CARN Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling MIC-CARN + B6/B12/LIDOCAINE injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Product
MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1011-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-961-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-958-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-939-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls B-Complex/Lidocaine Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-Complex/Lidocaine 2% Injection because FDA inspections raised concerns about quality control and sterility assurance.
Product
B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-951-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls DMPS Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling DMPS 50mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Product
DMPS 50mg/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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-959-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-964-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V440000·2013-09-18
Lion Bus Recalls 2013 360 School Buses for Seat Safety Defect
Lion Bus is recalling one 2013 360 school bus because its passenger seats do not absorb enough impact force in a crash, increasing injury risk.
Product
LION — LION 360
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-990-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Procaine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Procaine P/F 20 mg/ml injectable because FDA inspections raised concerns about sterility assurance and quality control.
Product
PROCAINE P/F 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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-977-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-982-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1035-2013·2013-09-18
Wellness Pharmacy Recalls Dexpanthenol Vials Due to Sterility Concerns
Wellness Pharmacy is recalling 1,355 vials of Dexpanthenol 250 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Product
Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-935-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls B-12/Lidocaine Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-12/Lidocaine 25/10mg/mL injections because FDA inspections raised concerns about sterility assurance and quality control.
Product
B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1030-2013·2013-09-18
Wellness Pharmacy Recalls Dexpanthenol Due to Microbial Contamination
Wellness Pharmacy is recalling Dexpanthenol 250mg/ml PF due to laboratory results indicating microbial contamination. The FDA expressed concern that the firm's contract testing lab results may not be reliable.
Product
Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-941-2013·2013-09-18
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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-966-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1029-2013·2013-09-18
Pharmacy Creations Recalls EDTA Disodium Injection Due to Sterility Concerns
Pharmacy Creations is recalling EDTA disodium 150 mg/mL sterile injection vials due to a lack of assurance of sterility.
Product
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1007-2013·2013-09-18
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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-950-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2178-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
The FDA is recalling Monoject flush syringes that may contain non-sterile water instead of saline or heparin, posing a risk of infection.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-937-2013·2013-09-18
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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-996-2013·2013-09-18
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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-934-2013·2013-09-18
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
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1034-2013·2013-09-18
Wellness Pharmacy Recalls RL Glutathione Due to Sterility Concerns
Wellness Pharmacy is recalling RL Glutathione 100 mg/mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Product
RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-994-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1004-2013·2013-09-18
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2194-2013·2013-09-18
Ormco Recalls Vector TAS 8mm Orthodontic Screws Due to Manufacturing Defect
Ormco is voluntarily recalling one lot of Vector TAS 8mm orthodontic screws because some were machined undersized, which may cause the screws to break during use.
Product
Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·13V444000·2013-09-18
Bloomer Evolution Trailers Recalled for Door Lock Jamming Hazard
Bloomer Trailers is recalling 2006-2013 Evolution models equipped with Fastec door locks that may jam, potentially trapping occupants inside the trailer.
Product
BLOOMER — BLOOMER EVOLUTION
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2013·2013-09-18
Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling 44 units of ADVIA Centaur Folate reagent due to calibration failures and significant negative shifts in quality control and patient results.
Product
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2175-2013·2013-09-18
B. Braun Outlook ES Pumps Recalled for Potential Drug Library Loss
B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2164-2013·2013-09-18
B. Braun Outlook ES Infusion Pumps Recalled for DoseGuard Software Defect
B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2013·2013-09-18
Berchtold Corp. Recalls OPERON D850 Surgical Tables Due to Malfunction
Berchtold Corp. is recalling 263 OPERON D850 surgical tables because they were not lowering. The units were distributed nationwide in the US and Canada.
Product
OPERON D850 Surgical Table Product Usage: Surgical Table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1022-2013·2013-09-18
University Compounding Pharmacy Recalls Testosterone Injection Due to Sterility Concerns
University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate/Testosterone Propionate Injection due to lack of assurance of sterility.
Product
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2013·2013-09-18
B. Braun Outlook ES Infusion Pumps Recalled for Key Panel Failure
B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1881-2013·2013-09-18
New Sun Immune 101 Dietary Supplement Recalled for E. coli Contamination
New Sun Inc is recalling Immune 101 dietary supplements due to positive E. coli test results. The voluntary recall affects 61,840 capsules distributed across 30 states.
Product
New Sun Immune 101, Dietary Supplement 360 Capsule bottles and 100 capsule bottles, New Sun, Inc, Hendersonville NC 28792 1-800-544-0777 www.newsun.net product No. 74-0
Category
Food
Distribution
31 states
HighFDA (Devices)·Z-2192-2013·2013-09-18
BD Microtainer Quikheel Lancet Recalled for Failure to Retract
Becton Dickinson is recalling BD Microtainer Quikheel Lancets because they may not retract after use, creating a risk of exposure to used sharps.
Product
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.
Category
Medical Device
Distribution
7 states
HighNHTSA·13V467000·2013-09-18
Spartan MM Motorhomes Recalled for Radiator Fan Blade Breakage Risk
Spartan Motors is recalling 2011-2012 MM motorhomes with Cummins ISC engines because radiator fan blades may break without warning, posing an injury risk to people near the engine.
Product
SPARTAN — SPARTAN MM
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1026-2013·2013-09-18
Park Compounding Recalls Sterile Injection Solutions Due to Sterility Concerns
Park Compounding is recalling Methylcobalamin, Multitrace-5, and Testosterone Cypionate injections due to lack of sterility assurance.
Product
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2170-2013·2013-09-18
Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
Product
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2176-2013·2013-09-18
Leica Surgical Microscope Recall Due to Brake Failure During Installation
Leica Microsystems is recalling five surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
Product
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2013·2013-09-18
Spine Wave Recalls Lumbar Intervertebral Fusion Implants Due to Material Error
Spine Wave, Inc. is recalling 17 units of the StaXx IB Convex Expandable Implant because the superior endplate was manufactured from a different polymer than specified.
Product
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2195-2013·2013-09-18
Sybron Recalls AOA Mini RPE Screw Assemblies Due to Incomplete Welds
Sybron Dental Specialties is recalling 1,091 AOA Mini RPE Screw Assemblies because they may have incomplete welds. These components are used in orthodontic devices like Herbst and MARA appliances.
Product
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed…
Category
Medical Device
Distribution
Distributed nationwide

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