FDA Drug recall D-1031-2013
Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
- FDA Drug
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 by Wellness Pharmacy, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1031-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-23 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wellness Pharmacy |
| Distribution | US |
Product
Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
Reason
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.
Identifiers
| code_info | Lot# 130613@38, Use By: 12/10/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1031-2013%22
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