The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1073-2020·Announced 2020-04-08

Medical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns

Medical Center Pharmacy is recalling specific lots of C-Albumin Eye Drop 10% S because production processes cannot assure sterility. Patients in Tennessee who received these prescriptions should contact their healthcare provider.

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, which corresponds to a Severe severity score (4) according to the rubric, as it involves a product where use may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Medical Center Pharmacy, Inc. is recalling C-Albumin Eye Drop 10% S, packaged in 10 mL bottles. The recall involves two specific lots identified by the codes 03042020@28 (Best Use Date: 03/18/2020) and 03032020@3 (Best Use Date: 03/17/2020). The product is prescription-only and was distributed to specific patients in Tennessee.

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 classification is designated as FDA Class II.

Patients who have received prescriptions for these specific lots of C-Albumin Eye Drop 10% S should contact their healthcare provider or pharmacist for further instructions. The recall is limited to the specific lots and distribution area mentioned above.

The recalled product

Product
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
Manufacturer
Medical Center Pharmacy, Inc.
Category
Drug — Ophthalmic
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 (2)

  • Lot: 03042020@28 BUD: 03/18/2020
  • 03032020@3 BUD: 03/17/2020

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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