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Class II: temporary or reversible health riskTerminated

Medistat RX All Products Intended to be Sterile Recall

All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave

Medistat RX L.L.C. · Foley, AL

Risk level
Class II
Reported by FDA
Oct 7, 2015
Recall ID
D-1833-2015
Check your lot numberHow we source this data

Summary

Medistat RX recalled All Products Intended to be Sterile starting Sep 10, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1833-2015 on Oct 7, 2015. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

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.

Lot numbers, UPCs & expiration codes

All Lots Not Expired and Distributed Before 8/5/15.

Where it was sold

U.S. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1833-2015
Classification
Class II
Status
Terminated
Recall initiated
Sep 10, 2015
FDA report date
Oct 7, 2015
Quantity
956,571 mL
Recall type
Voluntary: Firm initiated
Recalling firm
Medistat RX L.L.C.

Original FDA data

Every field from FDA enforcement report D-1833-2015, exactly as published.

Show all FDA fields
City
Foley
State
AL
Status
Terminated
Country
United States
Event ID
72163
Address
110 E Azalea Ave
Code information
All Lots Not Expired and Distributed Before 8/5/15.
Postal code
36535-2540
Report date
Oct 7, 2015
Product type
Drugs
Recall number
D-1833-2015
Classification
Class II
Recalling firm
Medistat RX L.L.C.
Product quantity
956,571 mL
Termination date
Aug 30, 2016
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
U.S. Nationwide
Recall initiation date
Sep 10, 2015
Initial firm notification
Telephone
Center classification date
Sep 29, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1833-2015, published Oct 7, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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