Vital Care Compounder Recalls Olopatadine Eye Drops for Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Olopatadine 0.8% Ophthalmic Solution 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 the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection or injury.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Olopatadine 0.8% Ophthalmic Solution, 3ml bottles. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is a prescription ophthalmic solution manufactured in Hattiesburg, MS. The specific lot number is 389278, with a use-by date of 8-9-16. The product was distributed in Mississippi.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- 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)
- Lot# 389278
- Use by 8-9-16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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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