Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
Hydroxocobalamin 1) 1000mcg/mL
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
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Drug: Hydroxocobalamin
- Recalling firm
- Fallon Wellness Pharmacy, L.L.C.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1075-2015 · 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 Hydroxocobalamin recalls
See all
Class II · Moderate risk
Hydroxocobalamin-Pf- 1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin 25MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL
Lack of assurance of sterility.
Other recalls by Fallon Wellness Pharmacy, L.L.C.
All 2015 recalls
Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk
Methylcobolamin 1) 6500 mcg/0.26mL
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection
Lack of assurance of sterility
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