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.
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 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.
- Category
- Drug — Compounded Medication
- 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 →Related recalls
Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
See all →- HighAnderson Compounding Pharmacy Recalls Prostaglandin Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereProstaglandin Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- SevereEstrone Oil Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- SevereAnderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereGentamicin Irrigation Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereMedical Center Pharmacy Recalls Gentamicin Bladder Irrigation Bags
FDA (Drugs) · 2020-04-08
- SevereRenacidin Irrigation Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12
- HighClindamycin/EDTA Calcium Irrigation Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01
- SevereGentamicin Irrigation Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-06-05
- HighOxyTOCIN Injectable Product Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- SevereGentamicin Irrigation Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2020-04-08