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.
Reported: April 8, 2020 Initiated: March 13, 2020 #D-1076-2020
Product Description
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.
Details
- Recalling Firm
- Medical Center Pharmacy, Inc.
- Units Affected
- 2 bags
- Distribution
- Specific prescriptions to patients in TN
- Location
- Cleveland, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medical Center Pharmacy, Inc.. Units affected: 2 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 8, 2020. Severity: Moderate. Recall number: D-1076-2020.
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