Polyhexamethylene Biguanide Ophthalmic Drops Recalled for Sterility Assurance Issues
Anderson Compounding Pharmacy is recalling Polyhexamethylene Biguanide 0.02% Ophthalmic Drops due to a lack of sterility assurance.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; lack of sterility assurance in ophthalmic products is a significant risk.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper. The recall is being conducted because of a lack of sterility assurance in the product.
The recalled product consists of 5 drop containers. The distribution pattern is nationwide, and the recall applies to all lots. The product was manufactured by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, located at 310 Bluff City Hwy, Bristol, TN.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Ophthalmic
- Affected units
- 5
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)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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