Aurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
Aurolab Trust is recalling FOCUS PI eye drops because the agency could not verify the product's sterility. Consumers in Virginia should stop using the product.
What this means for you
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 sterile ophthalmic product with a lack of assurance of sterility, which poses a significant risk of infection or injury.
Plain-English summary
Aurolab Trust is recalling 25,220 bottles of FOCUS PI (Hypromellose Eye Drops 0.7%) due to a lack of assurance of sterility. The product is an over-the-counter ophthalmic solution manufactured for Covalent Management, Inc. in Manassas, Virginia.
The recall involves two specific batches: Batch# 6B093FI with an expiration date of 04/01/28, and Batch# 6F511F1 with an expiration date of 05/15/28. The affected units were distributed in Virginia (VA).
Consumers who have purchased these specific batches should stop using the product immediately. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- FOCUS PI (HYPROMELLOSE EYE DROPS 0.7%)
- Brand
- FOCUS PI
- Manufacturer
- Aurolab Trust
- Category
- Drug — Ophthalmic
- Affected units
- 25,220
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 (4)
- Batch# 6B093FI
- Exp. 04/01/28
- Batch# 6F511F1
- Exp. 05/15/28
Distribution
Distributed in 1 state:
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