US Compounding Dexamethasone Sodium Phosphate PF Recall

Why it was recalled

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Product description

Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02

Lot numbers, UPCs & expiration codes

Lot Numbers: 20151407@13 BUD: 1/10/2016

Where it was sold

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-0250-2016
Classification: Class II
Status: Terminated
Recall initiated: Sep 12, 2015
FDA report date: Nov 25, 2015
Quantity: 235 vials
Recall type: Voluntary: Firm initiated
Recalling firm: US Compounding Inc

Original FDA data

Every field from FDA enforcement report D-0250-2016, exactly as published.

Show all FDA fields

City: Conway
State: AR
Status: Terminated
Country: United States
Event ID: 72179
Address: 1270 Don's Lane
Code information: Lot Numbers: 20151407@13 BUD: 1/10/2016
Postal code: 72032
Report date: Nov 25, 2015
Product type: Drugs
Recall number: D-0250-2016
Classification: Class II
Recalling firm: US Compounding Inc
Product quantity: 235 vials
Termination date: Mar 30, 2017
Reason for recall: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02
Distribution pattern: Nationwide
Recall initiation date: Sep 12, 2015
Initial firm notification: Letter
Center classification date: Nov 17, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0250-2016, published Nov 25, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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