Severity
Moderate
FDA Drug recall · Reported October 7, 2015
Lack of Assurance of Sterility
Medistat Rx L.L.C. recalled All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 3… - a moderate-severity action.
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 3… was recalled by Medistat Rx L.L.C. in October 7, 2015. Reason: Lack of Assurance of Sterility. Check the official notice for the remedy. Verify recall #D-1833-2015 with the FDA Drug before acting.
The recall
Medistat Rx L.L.C. issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility.
Sourced from official FDA Drug enforcement records. Verify recall #D-1833-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1833-2015) was formally reported on October 7, 2015, with the manufacturer initiating the action on September 10, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medistat Rx L.L.C. is listed as the recalling firm, operating out of Foley, AL. Federal records list the affected scope as 956,571 mL.
The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: U.S. Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
956,571 mL
Related Recalls
6
5 from same agency
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix (Papaverine/ Aloprostadil/ Phentolamine) Products, 5) All Testosterone Products, 6) All Dexamethasone Products, 7) All Levocarnitine Products, 8) All Hydroxyprogesterone Caproate Products, 9) All Triamcinolone Products, 10) All Betamethasone Sodium Phosphate Products, 11) All Methylprednisolone Acetate Products.
Lack of Assurance of Sterility
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1833-2015 |
| Date reported | October 7, 2015 |
| Date initiated | September 10, 2015 |
| Recalling firm | Medistat Rx L.L.C. |
| Firm location | Foley, AL |
| Affected scope | 956,571 mL |
| Distribution | U.S. Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 7, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.