Unique Pharmaceutical All sterile products within expiry Recall

Why it was recalled

Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Product description

All sterile products 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-0012-2015
Classification: Class II
Status: Terminated
Recall initiated: Jul 18, 2014
FDA report date: Oct 15, 2014
Quantity: 325,225 units (syringes, vials, bags)
Recall type: Voluntary: Firm initiated
Recalling firm: Unique Pharmaceutical, Ltd

Original FDA data

Every field from FDA enforcement report D-0012-2015, exactly as published.

Show all FDA fields

City: Temple
State: TX
Status: Terminated
Country: United States
Event ID: 68841
Address: 5920 S General Bruce Dr
Address (line 2): Ste 100
Code information: All Lots
Postal code: 76502-5803
Report date: Oct 15, 2014
Product type: Drugs
Recall number: D-0012-2015
Classification: Class II
Recalling firm: Unique Pharmaceutical, Ltd
Product quantity: 325,225 units (syringes, vials, bags)
Termination date: Feb 24, 2016
Reason for recall: Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Voluntary / mandated: Voluntary: Firm initiated
Product description: All sterile products within expiry
Distribution pattern: Nationwide
Recall initiation date: Jul 18, 2014
Initial firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date: Oct 9, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0012-2015, published Oct 15, 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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