Abbott's Compounding Pharmacy, Inc.: Sterile Compounded Products Recalled for Potential Lack of Sterility

Agency Publication Date: August 17, 2016

Summary

Abbott's Compounding Pharmacy, Inc. is recalling 95 units of unexpired sterile compounded products, including Cyclosporine and Prednisolone Acetate, following an FDA inspection. The recall was initiated because the products may lack sterility assurance, meaning they could be contaminated with bacteria or fungi. Consumers who have these veterinary medications should stop using them and contact their healthcare provider or pharmacist immediately.

Risk

Products that are intended to be sterile but lack proper sterility assurance can cause serious infections if administered. While no injuries have been reported, contaminated medications pose a medium risk of harm depending on the patient's health and the route of administration.

What You Should Do

Check your medication labels for the following products: Cyclosporine 1% (10 ml), Cyclosporine 2% (15 ml), or Prednisolone Acetate 25 mg/ml (40 ml).
Look for specific identifiers: Cyclosporine 1% (Recall V-483-2016) compounded between 11/19/15 and 12/22/15; Cyclosporine 2% (Recall V-484-2016) compounded on 12/22/15; or Prednisolone Acetate (Recall V-485-2016) compounded on 09/09/15.
If you identify an affected product, stop using it immediately to avoid the risk of infection.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any issues.
Return any unused portions of the recalled medication to Abbott's Compounding Pharmacy, Inc. at 2320 Woolsey St, Berkeley, CA 94705, for a refund.
For additional questions, you may contact the FDA's consumer complaint coordinator or call the FDA at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

Full Refund

Drug recall refund and guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cyclosporine 1% (10 ml)

Model:

V-483-2016

Lot Numbers:

Compounded 11/19/15 to 12/22/15

Product: Cyclosporine 2% (15 ml)

Model:

V-484-2016

Lot Numbers:

Compounded 12/22/15

Product: Prednisolone Acetate 25 mg/ml (40 ml)

Model:

V-485-2016

Lot Numbers:

Compounded 09/09/15

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73116

Status: Resolved

Manufacturer: Abbott's Compounding Pharmacy, Inc.

Sold By: Abbott's Compounding Pharmacy, Inc.

Manufactured In: United States

Units Affected: 3 products (40 ml; 15 ml; 40 ml)

Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

Summary

What You Should Do

Check your medication labels for the following products: Cyclosporine 1% (10 ml), Cyclosporine 2% (15 ml), or Prednisolone Acetate 25 mg/ml (40 ml).

Look for specific identifiers: Cyclosporine 1% (Recall V-483-2016) compounded between 11/19/15 and 12/22/15; Cyclosporine 2% (Recall V-484-2016) compounded on 12/22/15; or Prednisolone Acetate (Recall V-485-2016) compounded on 09/09/15.

If you identify an affected product, stop using it immediately to avoid the risk of infection.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any issues.

Return any unused portions of the recalled medication to Abbott's Compounding Pharmacy, Inc. at 2320 Woolsey St, Berkeley, CA 94705, for a refund.

For additional questions, you may contact the FDA's consumer complaint coordinator or call the FDA at 1-888-INFO-FDA (1-888-463-6332).