Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

27576–27600 of 32222

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