Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Pyridoxine HCL 100mg/Ml W/Pres
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
Drug: Pyridoxine
- Recalling firm
- Medaus, Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1236-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pyridoxine recalls
See all
Class II · Moderate risk
B6 (Pyridoxine HCl) for Injections
Lack of Assurance of Sterility
Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Presence of Particulate Matter.
Other recalls by Medaus, Inc.
All 2016 recalls
Class II · Moderate risk
HCL 2mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 1mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine 100mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 10mg/Ml
Lack of Assurance of Sterility
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