Serum Tears 20% Drops Recalled for Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Serum Tears 20% Drops due to a lack of sterility assurance. All lots of the 1 mL droptainers are affected.
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. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in a drug product corresponds to a severity score of 4 (Severe).
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Serum Tears 20% Drops, 1 mL Droptainer. The recall is being conducted because the product lacks sterility assurance. The affected product consists of 40 drop containers.
The recall covers all lots of the product. The distribution pattern is listed as nationwide. The manufacturer is Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, located at 310 Bluff City Hwy, Bristol, TN.
Consumers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 40
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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