Archive
530 recalls were announced in September 2013.
Of the 530 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.
Which agencies issued them
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.
Beacon Hill Medical Pharmacy is recalling Estriol 5 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Testosterone Hypoallergenic and Testosterone Aqueous injectables due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Manganese Sulfate 0.1 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
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.
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Dibasic/Water for Injection 10% because FDA inspections raised concerns about quality control and sterility assurance.
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.
Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection vials because the company cannot guarantee the product is sterile.
Beacon Hill Medical Pharmacy is recalling Phosphatidylcholine 50 mg/mL Injectable because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to sterility assurance concerns identified during an FDA inspection.
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.
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.
Beacon Hill Medical Pharmacy is recalling Vitamin D 50,000 I.U./ML Injectable due to FDA inspectional findings regarding sterility assurance and quality control.
Wellness Pharmacy is recalling Methyl B12 1 mg/mL single-use vials because laboratory results indicated microbial contamination and the FDA questioned the reliability of the testing.
NOV Rolligon is recalling specific 2011-2012 trailers because a missing weld on the rear suspension could cause the trailer to pull to one side or shift load, increasing crash risk.
Beacon Hill Medical Pharmacy is recalling EDETATE DISODIUM 150 MG/ML INJECTABLE because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Beacon Hill Medical Pharmacy is recalling Multitrace-5 Injectable because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Beacon Hill Medical Pharmacy is recalling Furosemide 10 mg/mL injectable products because FDA inspectional findings raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Selenium 400 mcg/mL injectable because FDA inspections raised concerns about quality control and sterility assurance.
Wellness Pharmacy is recalling RL Glutathione 100 mg/mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Beacon Hill Medical Pharmacy is recalling PUMICE/LIDOCAINE HCL 1.5%/1% Injection Suspensions because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Freamine III Alt 8.5% Injectable due to sterility assurance concerns identified during an FDA inspection.
Beacon Hill Medical Pharmacy is recalling Chromium 4 mcg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
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.
Beacon Hill Medical Pharmacy is recalling Bi-Mix Phentolamine/Papaverine injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Lipo-Plex Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded progesterone and testosterone injections due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-Complex/Lido/B-12 injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded cyanocobalamin injections because FDA inspections raised concerns about sterility assurance and quality control.
Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
Beacon Hill Medical Pharmacy is recalling Arginine (R-Gene) 100 mg/mL injectable because FDA inspectional findings raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Alprostadil 100 mcg/mL injection solution because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding sterility assurance.
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.
Beacon Hill Medical Pharmacy is recalling compounded sterile injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Ascorbic Acid 500 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Glutathione 200 mg/mL injection solution because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Oxytocin 10 Units/mL because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded Triamcinolone Acetonide injections because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Zinc Sulfate 1 mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
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.
Beacon Hill Medical Pharmacy is recalling Quad Amino Blend 150/75/150/75 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling DMPS 50mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-12/Lidocaine 25/10mg/mL injections because FDA inspections raised concerns about sterility assurance and quality control.
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.
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.
Beacon Hill Medical Pharmacy is recalling Bi-Tropin S-2 Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable due to sterility assurance concerns identified during an FDA inspection.
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.
Beacon Hill Medical Pharmacy is recalling Estradiol Valerate with Lidocaine injection because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded buprenorphine cream due to sterility assurance concerns identified during an FDA inspection.
Beacon Hill Medical Pharmacy is recalling Procaine P/F 20 mg/ml injectable because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Copper 0.4mg/mL Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling TRI-MIX injection solutions because FDA inspectional findings raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Ketorolac Tromethamine 60 mg/mL injectable because FDA inspectional findings raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded B12/E2/E3/PROG/TEST injectable solution due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Hydrogen Peroxide 3% Injectable because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-Complex/Lidocaine 2% Injection because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling DMSO 50% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
South Coast Specialty Compounding is voluntarily recalling Testosterone Cypionate injections due to a lack of sterility assurance.
Beacon Hill Medical Pharmacy is recalling Triple-Testosterone oil injection solutions because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded HCG vials because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling MIC-CARN + B6/B12/LIDOCAINE injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Sodium Hydroxide 10% Injection due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Lipolic Acid injectable products because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling L-Tryptophan 300 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded Nandrolone Decanoate injections due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded glutamine injection solution due to FDA inspectional findings regarding sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Pyridoxine HCL Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Sulfate 50% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
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.
Beacon Hill Medical Pharmacy is recalling Glycine 50 mg/mL injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Ascorbic Acid 500 mg/mL injectable products due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Vitamin B-Complex Injectable products because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
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.
New Sun Inc. is voluntarily recalling JLB Combination dietary supplements due to positive E. coli test results.
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.
GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.
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.
Xlumena is recalling 148 units of the NAVIX Access Device because a complaint investigation found the catheter can fracture at the distal end under load.
Beacon Hill Medical Pharmacy is recalling Sermorelin Acetate 10 mg injectable because FDA inspectional findings raised concerns about sterility assurance and quality control.
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.
B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.
B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.
Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Park Compounding is recalling Methylcobalamin, Multitrace-5, and Testosterone Cypionate injections due to lack of sterility assurance.
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.
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.
Berchtold Corp. is recalling 263 OPERON D850 surgical tables because they were not lowering. The units were distributed nationwide in the US and Canada.
Leica Microsystems is recalling five surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
University Compounding Pharmacy is voluntarily recalling PGE-1 injections due to lack of assurance of sterility. The recall affects nationwide distribution.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
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.
University Compounding Pharmacy is voluntarily recalling PGE-1, 20 mcg/mL Injection in Normal Saline due to lack of assurance of sterility.
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.
B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.
Bloomer Trailers is recalling 2006-2013 Evolution models equipped with Fastec door locks that may jam, potentially trapping occupants inside the trailer.
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.
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