FDA Drug recall D-1582-2015
Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- FDA Drug
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN by The Compounding Pharmacy, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1582-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-02 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Compounding Pharmacy |
| Distribution | US |
Product
Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Identifiers
| code_info | All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1582-2015%22
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