Medical Center Pharmacy Recalls Gentamicin Bladder Irrigation Bags
Medical Center Pharmacy is recalling 250 mL bags of Gentamicin/Bacitracin Bladder Irrigation due to concerns that production processes cannot assure sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile product where sterility cannot be assured is categorized as Severe due to the significant risk of infection.
Plain-English summary
Medical Center Pharmacy, Inc. is recalling 250 mL bags of C-*Gentamicin/Bacitracin Bladder Irrigation in N.S. (NDC 63323-0010-02). The recall is limited to 2 bags from Lot 03022020@3, which had a beyond-use date of 03/16/2020.
The recall was initiated due to a lack of assurance of sterility. The firm identified concerns with production processes that cannot guarantee the sterility of products intended to be sterile. This is a prescription-only medication.
The affected product was distributed via specific prescriptions to patients in Tennessee. Patients who received this medication should contact their healthcare provider or pharmacist for further instructions on whether to discontinue use or obtain a replacement.
The recalled product
- 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.
- Manufacturer
- Medical Center Pharmacy, Inc.
- Category
- Drug — Sterile Irrigation
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 03022020@3 BUD: 03/16/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Medical Center Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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