Altaire Recalls OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic
Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% sterile anesthetic single-dose vials due to a lack of assurance of sterility.
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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a sterile ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL vials. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is a prescription-only ophthalmic anesthetic manufactured by Altaire Pharmaceuticals, Inc. for OCuSOFT, Inc. The recall covers 14,091 cartons distributed nationwide in the United States. Specific lot codes and expiration dates associated with the recall include 17236 (8/19), 17334 (11/19), and 18015 (1/20).
Healthcare providers and consumers should stop using the affected product and contact Altaire Pharmaceuticals or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Anesthetic
- Hazard
- Affected units
- 14,091
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 (1)
- 17236 8/19 17334 11/19 18015 1/20
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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