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 recall is classified as FDA Class II and involves a sterile ophthalmic product with sterility assurance concerns, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling Vancomycin Ophthalmic Solution, 30mg/ml, 10ml vials. The recall covers products with expiration dates from January 2013 to April 19, 2013.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product. The agency classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Ophthalmic
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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