The Recall Desk
SevereFDA (Drugs)·D-1833-2015·Announced 2015-10-07

Medistat RX Recalls Sterile Products Due to Sterility Assurance Concerns

Medistat RX L.L.C. is recalling all sterile products, including various injectable medications, due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.

Plain-English summary

Medistat RX L.L.C. is recalling all products intended to be sterile manufactured by mediStat Pharmacy in Foley, Alabama. The recall includes an incomplete list of specific products, such as Cyanocobalamin, Magnesium Chloride, Lipostat (MIC B12), Trimix, Testosterone, Dexamethasone, Levocarnitine, Hydroxyprogesterone Caproate, Triamcinolone, Betamethasone Sodium Phosphate, and Methylprednisolone Acetate products.

The reason for the recall is a lack of assurance of sterility. The recall covers 956,571 mL of product distributed nationwide in the United States. The affected lots are all those that were not expired and distributed before August 5, 2015.

Consumers and healthcare providers should stop using these products and contact Medistat RX L.L.C. for further instructions or a refund.

The recalled product

Product
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 (Pa
Manufacturer
Medistat RX L.L.C.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.