Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Lipoplex
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility for injectables and solutions intended to be sterile.
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
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Drug: Pyridoxine
- Recalling firm
- Customceutical Compounding
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1257-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Customceutical Compounding
All 2019 recalls
Class II · Moderate risk
TriMix MEDIUM
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Trimix HIGH
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test PROCYP
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
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