CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Dexpanthenol 250 mg/mL PF, Single Use Vial recalled by Wellness Pharmacy
Wellness Pharmacy is recalling Dexpanthenol 250 mg/mL PF, Single Use Vial, Wellness Pharmacy, 1-800-227-2627, distributed nationwide in the US. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1035-2013
- FDA event ID
- 66188
- Recalling firm
- Wellness Pharmacy, Birmingham, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Aug 2013 | Recall initiated by company | |
| 12 Sep 2013 | Classified by FDA | +20 days |
| 18 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Dexpanthenol 250 mg/mL PF, Single Use Vial, Wellness Pharmacy, 1-800-227-2627 recalled?
Yes. Wellness Pharmacy recalled Dexpanthenol 250 mg/mL PF, Single Use Vial, Wellness Pharmacy, 1-800-227-2627 on 23 Aug 2013. The recall is Class II and its status is Terminated. Recall number D-1035-2013.
Why was it recalled?
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.
Which lots are affected?
Lot# 130605@52, Exp. 12/2/13
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Wellness Pharmacy
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NA. Phenylbutyrate 200 mg/mL, Sdv, a), b), and c) recalled | Wellness Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Methyl B12 1 mg/mL P.F., Single-Use Vial, a), b) recalled | Wellness Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Magnesium Sulfate Hepta 50% PF, Single Use Vial, a), b) recalled | Wellness Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | RL Glutathione 100 mg/mL, Sdv PF,a), b), c), and d) recalled | Wellness Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Dexpanthenol 250mg/ml PF, Qty:, Wellness Pharmacy, 1 recalled | Wellness Pharmacy | Sterility | Nationwide |