Nora Apothecary Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns
Nora Apothecary is recalling Tobramycin 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 lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling Tobramycin Opth Soln 13mg/ml, 7ml Ophthalmic Solution. 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 due to FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility. The agency classified this recall as Class II.
Consumers should stop using the recalled products and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Ophthalmic Solution
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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