The Recall Desk
SevereFDA (Drugs)·D-1192-2019·Announced 2019-04-24

Anderson Compounding Pharmacy Recalls Gentamicin Sterile Water for Irrigation

Anderson Compounding Pharmacy is recalling Gentamicin 160 mg/1000 mL Sterile Water for Irrigation 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a sterile irrigation product, which poses a significant risk of infection and potential hospitalization, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

Anderson Compounding Pharmacy, Inc. is recalling Gentamicin 160 mg/1000 mL Sterile Water for Irrigation, 1000 mL bottles. The recall was initiated because the product lacks sterility assurance.

The affected product is distributed nationwide. All lots of the product are included in this recall. The source text does not specify the number of units affected or the specific dates of distribution.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The source text does not provide specific contact information for the recalling firm.

The recalled product

Product
Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

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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