FDA Recalls Atropine Eye Drops Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling Atropine 0.01% Eye Drops because the product lacks sterility assurance. The recall covers all lots distributed nationwide.
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 adverse health consequences (such as lack of sterility assurance) are categorized as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, manufactured by Anderson Compounding Pharmacy, Inc. The recall is due to a lack of sterility assurance in the product.
The recall includes all lots of the affected eye drops. The products were distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased these eye drops should stop using them and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Ophthalmic
- Hazard
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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