The Recall Desk
SevereFDA (Drugs)·D-473-2013·Announced 2013-06-05

Nora Apothecary Recalls Dexamethasone Ophthalmic Solution Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling 7 units of Dexamethasone Opth Soln 0.1% PF due to lack of assurance of sterility identified during an FDA inspection.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an ophthalmic product, which poses a risk of serious injury or death, meeting the criteria for a Severe rating.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling 7 units of Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln. The recall is being conducted because FDA inspection findings resulted in concerns regarding quality control processes, specifically a lack of assurance of sterility.

The affected products are distributed nationwide and include all products within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). The agency has classified this recall as Class II.

Consumers who possess these products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
7

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

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