Nora Apothecary Recalls PHMB Ophthalmic Solution Due to Sterility Concerns
Nora Apothecary is recalling PHMB Ophthalmic Solution 0.02% because FDA inspections raised concerns about quality control and sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure in an ophthalmic solution) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling 2 units of PHMB Opth Soln 0.02%, 10 ml Ophthalmic Solution. The recall covers products with expiration dates ranging from January 2013 to April 19, 2013, which were distributed nationwide.
The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers who have this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Ophthalmic Solution
- 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.
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