US Compounding Prednisolone Sodium Phosphate PF Solution 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

Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653

Lot numbers, UPCs & expiration codes

Lot Code: 20150209@16 BUD: 10/2/2015

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-0279-2016
Classification: Class II
Status: Terminated
Recall initiated: Sep 12, 2015
FDA report date: Nov 25, 2015
Quantity: 1 bottle
Recall type: Voluntary: Firm initiated
Recalling firm: US Compounding Inc

Original FDA data

Every field from FDA enforcement report D-0279-2016, 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 Code: 20150209@16 BUD: 10/2/2015
Postal code: 72032
Report date: Nov 25, 2015
Product type: Drugs
Recall number: D-0279-2016
Classification: Class II
Recalling firm: US Compounding Inc
Product quantity: 1 bottle
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: Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
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-0279-2016, 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.

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.