The Recall Desk
SevereFDA (Drugs)·D-1137-2019·Announced 2019-04-24

Acetylcysteine Eye Drops Recalled for Lack of Sterility Assurance

Anderson Compounding Pharmacy is recalling Acetylcysteine 10% Ophthalmic Eye Drops due to a lack of sterility assurance.

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, and the hazard involves a lack of sterility assurance in an ophthalmic product, which poses a significant risk of infection or injury.

Plain-English summary

Anderson Compounding Pharmacy, Inc. is recalling Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainers. The recall is due to a lack of sterility assurance in the product.

The affected product consists of 10 drop containers distributed nationwide. The recall covers all lots of the product.

Consumers should stop using the recalled eye drops and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Affected units
10

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 →

Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

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