The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1074-2020·Announced 2020-04-08

Medical Center Pharmacy Recalls Vancomycin Opthal Drops Due to Sterility Concerns

Medical Center Pharmacy is recalling Vancomycin Opthal 14 mg drops because production processes could not assure sterility. The product was distributed to patients in Tennessee.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in a sterile product is a significant hazard that aligns with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Medical Center Pharmacy, Inc. is recalling Vancomycin Opthal 14 mg drops, 5 mL bottles, NDC 67457-0340-01. The recall is due to concerns with production processes that cannot assure the sterility of the product, which is intended to be sterile.

The affected lot number is 03042020@7, with a beyond-use date of 03/18/2020. The product was distributed via specific prescriptions to patients in Tennessee.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on what to do next.

The recalled product

Product
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
Manufacturer
Medical Center Pharmacy, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1

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: 03042020@7 BUD: 03/18/2020

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.

See all 5 products in this recall →

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