The Recall Desk
SevereFDA (Drugs)·D-1180-2019·Announced 2019-04-24

Anderson Compounding Pharmacy Recalls Bacitracin Irrigation Due to Sterility Concerns

Anderson Compounding Pharmacy is recalling Bacitracin 3000U/30 mL Irrigation syringes nationwide 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 rubric specifies that FDA Class II recalls with potential for significant injury (such as lack of sterility assurance in a medical product) fall under the Severe category, particularly when structural or fundamental safety assurances are compromised.

Plain-English summary

Anderson Compounding Pharmacy, Inc. is recalling Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe. The recall covers all lots of the product, which is distributed nationwide. The specific reason for the recall is a lack of sterility assurance.

The product is a compounded medication used for irrigation. Because the sterility of the product is not assured, there is a potential risk of contamination. The source text does not specify the number of units recalled or report any specific illnesses or injuries associated with the product.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Affected units
2

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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