Altaire Recalls Tetcaine Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Tetcaine ophthalmic solution because the product may not be sterile. Patients should stop using the medication and consult a healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects are scored as 4 (Severe). While no specific injuries are reported in the text, the lack of sterility assurance in an ophthalmic product represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious adverse health consequences.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0.5 fl oz (15 mL), NDC 54799-502-15. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product was manufactured for OCuSOFT, Inc. and distributed nationwide in the United States. The recall covers 88,008 units with specific lot codes and expiration dates listed in the agency's records.
Patients who have this medication should stop using it and consult their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 88,008
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, 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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