Altaire Recalls OCuSOFT Ophthalmic Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT retaine NaCl Ophthalmic Ointment because the company cannot guarantee the product is sterile.
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 the hazard involves a lack of assurance of sterility for an ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 19,632 units of OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 1/8 oz (3.5 g). The recall is being conducted because the manufacturer lacks assurance of the product's sterility. The affected product is distributed by OCuSOFT, Inc. in Rosenberg, TX, and was distributed nationwide in the U.S.A.
The specific lot affected is identified by the following codes: Lot # SAP, 1/20, SFI 6/20, and TCI 3/21. Consumers should check their ophthalmic ointment for these specific lot and expiration dates. If the product matches the recalled lot, consumers should stop using it and contact the distributor or manufacturer for instructions on return or disposal.
The recalled product
- Product
- OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 19,632
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)
- Lot #: SAP 1/20 SFI 6/20 TCI 3/21
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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