The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1138-2019·Announced 2019-04-24

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.

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, 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.
Manufacturer
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
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.

See all 68 products in this recall →

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