Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product description
Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lot numbers, UPCs & expiration codes
All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015
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-1582-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2015
- FDA report date
- Sep 23, 2015
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Compounding Pharmacy of America
Original FDA data
Every field from FDA enforcement report D-1582-2015, exactly as published.
Show all FDA fields
- City
- Knoxville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 71371
- Address
- 6216 Highland Place Way Ste 101-A
- Code information
- All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015
- Postal code
- 37919-4068
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1582-2015
- Classification
- Class II
- Recalling firm
- The Compounding Pharmacy of America
- Termination date
- Feb 10, 2016
- Reason for recall
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 2, 2015
- Initial firm notification
- Telephone
- Center classification date
- Sep 15, 2015