The Recall Desk
SevereFDA (Drugs)·D-467-2013·Announced 2013-06-05

Nora Apothecary Recalls Vancomycin Ophthalmic Solution Due to Sterility Concerns

Nora Apothecary is recalling Vancomycin Ophthalmic Solution because FDA inspections raised concerns about quality control and sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in ophthalmic products) fall under the Severe category.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling two units of Vancomycin Ophthalmic Solution, 25mg/ml, 10ml bottles. The recall covers all products within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). The products were distributed nationwide.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the ophthalmic solution. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Ophthalmic Solution
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)

  • 2013 (Jan. 2013 to April 19
  • 2013).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 43 recalled by Nora Apothecary and Alternative Therapies, 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 43 products in this recall →

Related recalls

Same manufacturer · Nora Apothecary and Alternative Therapies, Inc.

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Same hazard · sterility concern

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