Apothecure The firm is recalling all lots of sterile Recall

Why it was recalled

Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

Product description

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

Lot numbers, UPCs & expiration codes

All Lots

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-1066-2014
Classification: Class II
Status: Terminated
Recall initiated: Apr 15, 2013
FDA report date: Feb 12, 2014
Recall type: Voluntary: Firm initiated
Recalling firm: Apothecure, Inc

Original FDA data

Every field from FDA enforcement report D-1066-2014, exactly as published.

Show all FDA fields

City: Dallas
State: TX
Status: Terminated
Country: United States
Event ID: 64921
Address: 4001 Mcewen Rd Ste 100
Code information: All Lots
Postal code: 75244-5021
Report date: Feb 12, 2014
Product type: Drugs
Recall number: D-1066-2014
Classification: Class II
Recalling firm: Apothecure, Inc
Termination date: Dec 9, 2016
Reason for recall: Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Voluntary / mandated: Voluntary: Firm initiated
Product description: The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
Distribution pattern: Nationwide
Recall initiation date: Apr 15, 2013
Initial firm notification: Press Release
Center classification date: Feb 4, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1066-2014, published Feb 12, 2014. 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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