FDA Recalls Pre-Op Pledget Soln + Tetracaine Due to Sterility Concerns
Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln + Tetracaine vials because the agency cannot ensure the product is sterile.
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, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard of non-sterility in an ophthalmic solution carries a significant risk of infection, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Pre-Op Pledget Soln + Tetracaine, a prescription compound manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, Mississippi. The recall involves 6 vials of the 3ml solution, identified by Lot # 397269 with a use-by date of 9/20/16. The product was distributed in Mississippi.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a risk of infection if used.
Consumers and healthcare providers who have this specific lot of the product should stop using it immediately. They should contact their healthcare provider or the recalling firm for further instructions on how to dispose of or return the product.
The recalled product
- Product
- Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic Compound
- Affected units
- 6
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# 397269
- Use be 9/20/16
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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