Drug recall: Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627
Wellness Pharmacy, Inc. (Birmingham, AL) initiated this drug recall on 23 Aug 2013; FDA lists 6 product records under event 66188, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 3 Jun 2014. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Wellness Pharmacy, Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Wellness Pharmacy, Inc., Birmingham, AL.
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."
Distribution
"Nationwide and Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1030-2013 | Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 | 1355 units | Class II | Terminated | 18 Sep 2013 |
| D-1031-2013 | Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 | 590 Vials | Class II | Terminated | 18 Sep 2013 |
| D-1032-2013 | Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 | 2687 Vials | Class II | Terminated | 18 Sep 2013 |
| D-1033-2013 | NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627 | 200 Vials | Class II | Terminated | 18 Sep 2013 |
| D-1034-2013 | RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627 | 34 Vials | Class II | Terminated | 18 Sep 2013 |
| D-1035-2013 | Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627 | 1355 Vials | Class II | Terminated | 18 Sep 2013 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Jun 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.