Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Pyridoxine HCL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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 (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Affected NDC
72627-2424-01
Compare with the code on your package — it is the most precise check available.
Drug: Pyridoxine
- Recalling firm
- Empower Pharmacy
- NDC code
- 72627-2424-1
- Origin
- TX, United States
- FDA recall number
- D-0663-2024 · 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
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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
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Presence of Particulate Matter.
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Other sterility / contamination recalls from 2024
All sterility / contamination recalls
Class II · Moderate risk
phenylephrine in 0.9% Sodium Chloride Inj
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk
ketamine inj 50 mg per 1 mL
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class II · Moderate risk
PROFESSIONAL Regener-Eyes
Lack of Sterility Assurance
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