CLASS II Drug recall · Reported 7 Oct 2015 · FDA Enforcement Report
All Products Intended to be Sterile, mediStat Pharmacy recalled
Medistat RX is recalling All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL, distributed nationwide in the US. The recall was initiated on 10 Sep 2015 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-1833-2015
- FDA event ID
- 72163
- Recalling firm
- Medistat RX, Foley, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2015
- FDA classified
- 29 Sep 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 10 Sep 2015 | Recall initiated by company | |
| 29 Sep 2015 | Classified by FDA | +19 days |
| 7 Oct 2015 | Published in enforcement report | +8 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
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
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All Lots Not Expired and Distributed Before 8/5/15.
Where was it sold?
U.S. Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.