C-*Gentamicin/Bacitracin Bladder Irrigation in N — Class II drug recall D-1076-2020
Terminated recall by Medical Center Pharmacy, Inc., reported 2020-04-08, distributed in TN. Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of pro
| Recall number | D-1076-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Center Pharmacy, Inc., Cleveland, TN, United States |
| Recall initiated | 2020-03-13 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2022-10-14 |
| Distributed | TN |
| Quantity | 2 bags |
| Reason classes | sterility |
| NDC | 63323-0010-02 |
| Expiration dates | 2020-03-16 |
Product
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
Reason for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1076-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.