FDA Recalls Pre-Op Pledget Ophthalmic Drops Due to Sterility Concerns
Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln ophthalmic drops due to a lack of assurance of sterility. The recall affects 6 vials distributed in Mississippi.
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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in ophthalmic products) are rated as Severe (4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Pre-Op Pledget Soln, Ophthalmic Drops. The product is a prescription compound containing Tropicamide, Phenylephrine, Ketorolac, and Ofloxacin. The recall is being conducted by Pharmacy Plus, Inc. dba Vital Care Compounder, located in Hattiesburg, Mississippi.
The reason for the recall is a lack of assurance of sterility. The affected product consists of 6 vials, each 2ml, with Lot # 397267 and a use-by date of 9/20/16. The distribution pattern is limited to Mississippi.
Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic
- 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# 397267
- Use by 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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