Class II · Moderate risk
B5 Dexpanthenol for Injection
Lack of Assurance of Sterility
Dexpanthenol 250mg/ml PF
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627
Drug: Dexpanthenol
- Recalling firm
- Wellness Pharmacy, Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1030-2013 · 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 Dexpanthenol recalls
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Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/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.
Other recalls by Wellness Pharmacy, Inc.
All 2013 recalls
Class II · Moderate risk
Dexpanthenol 250 mg/mL PF
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Class II · Moderate risk
RL Glutathione 100 mg/mL
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Class II · Moderate risk
NA. Phenylbutyrate 200 mg/mL
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Class II · Moderate risk
Methyl B12 1 mg/mL P.F.
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
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