Clinical Specialties Compounding Pharmacy Mitomycin Recall

Why it was recalled

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Product description

Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Lot numbers, UPCs & expiration codes

Lot number CABDAGAD:68 , Exp date: 4/20/2013 and Lot number CABDAGAD:60, Exp date: 4/20/2013.

Where it was sold

FL, GA and SC.

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-657-2013
Classification: Class II
Status: Terminated
Recall initiated: Mar 20, 2013
FDA report date: Jul 10, 2013
Quantity: 6ml total
Recall type: Voluntary: Firm initiated
Recalling firm: Clinical Specialties Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-657-2013, exactly as published.

Show all FDA fields

City: Augusta
State: GA
Status: Terminated
Country: United States
Event ID: 64661
Address: 318 Baston Rd
Code information: Lot number CABDAGAD:68 , Exp date: 4/20/2013 and Lot number CABDAGAD:60, Exp date: 4/20/2013.
Postal code: 30907
Report date: Jul 10, 2013
Product type: Drugs
Recall number: D-657-2013
Classification: Class II
Recalling firm: Clinical Specialties Compounding Pharmacy
Product quantity: 6ml total
Termination date: Feb 22, 2017
Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Voluntary / mandated: Voluntary: Firm initiated
Product description: Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Distribution pattern: FL, GA and SC.
Recall initiation date: Mar 20, 2013
Initial firm notification: Telephone
Center classification date: Jul 3, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-657-2013, published Jul 10, 2013. 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.